A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer
Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT02141659
Collaborator
(none)
43
6
6
35.6
7.2
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naïve participants with non-metastatic prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The objective of this study is to evaluate the tolerability and safety of TAK-385 in hormone treatment-naive participants with non-metastatic prostate cancer. This study consists of two parts: Part A, multiple dose-rising (MRD) phase and Part B, an expansion phase.
Study Design
Study Type:
Interventional
Actual Enrollment
:
43 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of TAK-385 Alone in Hormone Treatment- naïve Japanese Patients With Non-metastatic Prostate Cancer
Actual Study Start Date
:
May 1, 2014
Actual Primary Completion Date
:
Apr 20, 2017
Actual Study Completion Date
:
Apr 20, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
Drug: TAK-385
TAK-385 Tablets.
|
| Experimental: Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
Drug: TAK-385
TAK-385 Tablets.
|
| Experimental: Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
Drug: TAK-385
TAK-385 Tablets.
|
| Experimental: Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
Drug: TAK-385
TAK-385 Tablets.
|
| Experimental: Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
Drug: TAK-385
TAK-385 Tablets.
|
| Experimental: Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
Drug: TAK-385
TAK-385 Tablets.
|
Outcome Measures
Primary Outcome Measures
- Part A: Number of Participants With Dose-limiting Toxicities (DLTs) [From treatment initiation until Day 28]
DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation >60 msec postdose.
- Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) [From treatment initiation until 40 days after last dose of study drug (Day 68)]
- Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities [From treatment initiation until 40 days after last dose of study drug (Day 68)]
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.
- Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters [From treatment initiation until 40 days after last dose of study drug (Day 68)]
- Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters [From treatment initiation until 40 days after last dose of study drug (Day 68)]
- Part B: Number of Participants Reporting One or More TEAE [From treatment initiation until 40 days after last dose of study drug (Day 712)]
- Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities [From treatment initiation until 40 days after last dose of study drug (Day 712)]
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase [GOT]) High, creatine kinase (CK) (creatine phosphokinase [CPK]) High, prothrombin time (PT)-international normalized ratio (INR) High.
- Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters [From treatment initiation until 40 days after last dose of study drug (Day 712)]
Here "BP" is blood pressure.
- Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters [From treatment initiation until 40 days after last dose of study drug (Day 712)]
Secondary Outcome Measures
- Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 [Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose]
- Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 [Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose]
- Part A: Serum Testosterone Concentrations for TAK-385 [Up to Day 35]
- Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF) [Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1)]
- Part B: Plasma Concentration of Unchanged TAK-385 [Up to Week 49 Day 1]
- Part B: Serum Testosterone Concentrations for TAK-385 [Up to Week 97 Day 1]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants judged by the investigator to have the capacity to understand the study and follow the study rules.
-
Participants whose written consent (signature or printed name and personal seal on informed consent form) can be obtained before any study procedures are performed.
-
Japanese male participants 20 or more years of age at the time of informed consent.
-
Participants who, if they have a female partner who could become pregnant, agree to practice appropriate means of contraception from the time of informed consent throughout the entire study treatment period and for 4 months after the last dose of study drug.
-
Participants in stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks (28 days) prior to study treatment initiation.
-
Participants with histologically or cytologically confirmed prostate cancer.
-
Participants whose clinical diagnosis is T1-4 N0 M0, or Tx N0 M0 for participants who have undergone radical prostatectomy.
-
Participants who are considered eligible for hormone therapy for prostate cancer.
-
Participants who have not received hormone therapy (example, gonadotropin-releasing hormone [GnRH] agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer.
-
Participants who have not undergone surgical castration.
-
Participants with serum testosterone at screening greater than (>) 150 nanogram per deciliter (ng/dL).
-
Participants meeting either of the following criteria for prostate-specific antigen (PSA) at screening. Untreated prostate cancer: PSA at screening > 4.0 nanogram per milliliter (ng/mL) Treated* prostate cancer: PSA at screening > 0.2 ng/mL.
- Participants who have undergone prostatectomy or either or both of high intensity focused ultrasound therapy or radiotherapy (excluding 125I-brachytherapy) prior to the start of this study.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status [17] of 0 or 1.
-
Body mass index (BMI) at screening greater than or equal to (>=) 18.0 kilogram per square meter (kg/m^2).
Exclusion Criteria:
-
Participants exhibiting symptoms judged related to prostate cancer by the investigator (example, bone pain, pelvic pain, ureteral obstruction) who urgently require hormone therapy such as GnRH agonist, GnRH antagonist, or CAB/MAB therapy, chemotherapy, or radiotherapy.
-
Participants who have received 5-alpha reductase inhibitors (except for participants who have been treated for male-pattern alopecias).
-
Participants who have received chemotherapy for prostate cancer (including estramustine).
-
Participants who have received 125I-brachytherapy.
-
Participants who received radiotherapy (except for 125I-brachytherapy) within 16 weeks (112 days) before study treatment initiation.
-
Participants who underwent prostatectomy within 16 weeks (112 days before study treatment initiation.
-
Treatment with any investigational compound within the 4 weeks (28 days) prior to the first dose of study drug or ongoing participation in another experimental trial related to the treatment of prostate cancer.
-
Diagnosis or treatment for another systemic malignancy within 2 years before study treatment initiation, or who had received a diagnosis of another malignancy before that and have evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ who have undergone complete resection will not be excluded from the study.
-
Participants taking drugs with moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitory or inducing effects, or any medications, supplements, or food products with P-glycoprotein (P-gp) inhibitory effects, in the 2 weeks (14 days) prior to study treatment initiation.
-
Participants who have received TAK-385 in a past clinical study.
-
Participants for whom it would be difficult to collect blood from a peripheral vein.
-
Participants with uncontrolled and clinically significant nervous, circulatory, pulmonary, hepatic, renal, metabolic, gastrointestinal, urogenital, or endocrine disorders, or other abnormalities (except for the targeted disease) that could affect study participation or the study results. Also, participants meeting any of criteria a through c below.
-
Participants with uncontrolled diabetes (Hemoglobin A1c [HbA1C] > 8 percent [%] at screening). However, participants whose HbA1c is brought under control with diabetes medications may be rescreened.
-
Participants with uncontrolled hypertension (systolic blood pressure > 150 millimeter of mercury (mmHg) and diastolic blood pressure > 90 mmHg at 2 separate measurements taken no more than 60 minutes apart at screening). Participants whose blood pressure is brought under control by antihypertensive medication may be rescreened.
-
Participants with myocardial infarction, unstable symptomatic ischemic heart disease, arrhythmias of common terminology criteria for adverse events (CTCAE) Grade > 2, thromboembolism (deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other heart diseases (example, pericardial effusion, restrictive cardiomyopathy). However, chronic stable atrial fibrillation controlled by stable anticoagulant therapy will be allowed.
-
Participants with bilateral hydronephrosis or bladder neck outlet obstruction.
-
Known hypersensitivity to TAK-385, TAK-385 excipients, or gonadotropin-releasing hormone (GnRH) antagonists.
-
Participants with a past history of gastrointestinal tract treatments (including gastrectomy) or gastrointestinal disease that could affect the drug absorption or tolerability (malabsorption, esophageal reflux, peptic ulcer, erosive esophagitis).
-
Participants positive for hepatitis B surface antigens (HBsAg), hepatitis C antibodies (HCV), human immunodeficiency virus (HIV) antibodies, or serologic test for syphilis, or with life-threatening disease other than cancer, at screening.
-
Clinically relevant electrocardiogram (ECG) abnormalities, or the following ECG abnormalities, at screening.
-
Q-wave infarction, unless identified 6 or more months prior to TAK-385 treatment initiation.
-
QTcF interval > 450 millisecond (msec) (when calculating the QTc interval, Fridericia's equation [QT/RR0.33] will be used).
-
Participants with congenital QT prolongation.
-
Current use of Class 1A or Class 3 antiarrhythmic medications.
-
New York Heart Association Class III or IV heart failure.
-
Participants with clinical laboratory abnormalities suggesting clinically relevant underlying disease, or with any of the following abnormal results, at screening.
-
Serum creatinine >= 2.0 mg/dL.
-
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 1.5*upper limit of normal (ULN) for the study site.
-
Total bilirubin >= 2*ULN for the study site.
-
Neutrophil count less than (<) 1,500 per cubic millimeter (/mm^3), platelet count < 100,000 per microliter (/mcL), hemoglobin < 10.0 g/dL.
-
Results of heart-related tests (creatine kinase MB [CK-MB] and cardiac troponin
- exceeding the study sites reference value.
-
Participants found to have clinical problems on the basis of examination findings, ECG findings, or chest X-ray findings at screening.
-
Participants considered unlikely by investigators to be able to follow the study protocol or considered ineligible for the study by investigators for other reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sakura-shi | Chiba | Japan | ||
| 2 | Maebashi-shi | Gunma | Japan | ||
| 3 | Sapporo-shi | Hokkaido | Japan | ||
| 4 | Kanazawa-shi | Ishikawa | Japan | ||
| 5 | Yokohama-shi | Kanagawa | Japan | ||
| 6 | Chiyoda-ku | Tokyo | Japan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02141659
Other Study ID Numbers:
- TAK-385/TB-AK160108
- U1111-1156-6034
First Posted:
May 19, 2014
Last Update Posted:
Nov 19, 2018
Last Verified:
Apr 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 7 investigative sites in Japan from 01 May 2014 to 20 April 2017. |
|---|---|
| Pre-assignment Detail | Japanese participants with hormone treatment-naive prostate cancer were enrolled in this study to receive TAK-385 loading dose (320 or 360 milligram [mg]) and maintenance dose (80, 120 or 160 mg) in two parts: Part A, dose-escalation phase, cohorts 1-4 and Part B, dose-expansion phase, cohorts 1-2. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Period Title: Overall Study | ||||||
| STARTED | 3 | 4 | 3 | 3 | 15 | 15 |
| COMPLETED | 3 | 3 | 3 | 3 | 13 | 13 |
| NOT COMPLETED | 0 | 1 | 0 | 0 | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | Total of all reporting groups |
| Overall Participants | 3 | 4 | 3 | 3 | 15 | 15 | 43 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
73.3
(5.51)
|
72.0
(5.60)
|
75.0
(6.08)
|
71.7
(3.51)
|
74.5
(4.84)
|
74.4
(5.53)
|
74.0
(5.00)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
3
100%
|
4
100%
|
3
100%
|
3
100%
|
15
100%
|
15
100%
|
43
100%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||||||
| Count of Participants [Participants] |
0
0%
|
||||||
| Region of Enrollment (participants) [Number] | |||||||
| Japan |
3
100%
|
4
100%
|
3
100%
|
3
100%
|
15
100%
|
15
100%
|
43
100%
|
| Height (centimeter (cm)) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [centimeter (cm)] |
166.0
(5.57)
|
167.0
(3.92)
|
162.3
(3.06)
|
160.3
(4.16)
|
163.4
(3.94)
|
164.7
(5.27)
|
164.1
(4.57)
|
| Weight (kilogram (kg)) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [kilogram (kg)] |
63.27
(8.361)
|
64.40
(9.542)
|
57.97
(2.857)
|
56.80
(1.992)
|
64.43
(7.891)
|
59.34
(5.440)
|
61.59
(7.017)
|
| Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [kilogram per square meter (kg/m^2)] |
22.90
(2.100)
|
23.03
(2.841)
|
22.00
(1.400)
|
22.17
(1.498)
|
24.17
(3.109)
|
21.93
(2.475)
|
22.90
(2.694)
|
Outcome Measures
| Title | Part A: Number of Participants With Dose-limiting Toxicities (DLTs) |
|---|---|
| Description | DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation >60 msec postdose. |
| Time Frame | From treatment initiation until Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The DLT analysis set included all participants enrolled in cohort A that meeting the following; who had taken at least 80 percent (%) of the doses of TAK-385 (23 doses) during the DLT evaluation period and for whom the DLT evaluation period observations had been completed or who had experienced DLTs during the DLT evaluation period. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 3 | 3 | 3 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) |
|---|---|
| Description | |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 68) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 4 | 3 | 3 |
| Count of Participants [Participants] |
3
100%
|
2
50%
|
3
100%
|
2
66.7%
|
| Title | Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities |
|---|---|
| Description | Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 68) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 4 | 3 | 3 |
| Grade 2: White Blood Cell Low |
1
33.3%
|
0
0%
|
0
0%
|
1
33.3%
|
| Grade 2: Neutrophil Count Low |
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
| Grade 2: Lymphocyte Count Low |
1
33.3%
|
1
25%
|
0
0%
|
0
0%
|
| Grade 2: Potassium Low |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
| Title | Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters |
|---|---|
| Description | |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 68) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 4 | 3 | 3 |
| Body Temperature <35.6 degree Celsius |
1
33.3%
|
1
25%
|
0
0%
|
0
0%
|
| Systolic BP >180 millimeter of Mercury (mmHg) |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
| Diastolic BP <50 mmHg |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
| Pulse <50 beats per minute (bpm) |
1
33.3%
|
1
25%
|
0
0%
|
0
0%
|
| Title | Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters |
|---|---|
| Description | |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 68) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 4 | 3 | 3 |
| Heart Rate <50 bpm |
1
33.3%
|
2
50%
|
0
0%
|
0
0%
|
| QT Interval >=460 millisecond (msec) |
1
33.3%
|
2
50%
|
0
0%
|
1
33.3%
|
| Title | Part B: Number of Participants Reporting One or More TEAE |
|---|---|
| Description | |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 712) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 15 |
| Count of Participants [Participants] |
15
500%
|
15
375%
|
| Title | Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities |
|---|---|
| Description | Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase [GOT]) High, creatine kinase (CK) (creatine phosphokinase [CPK]) High, prothrombin time (PT)-international normalized ratio (INR) High. |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 712) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 15 |
| Grade 2: White Blood Cell Low |
1
33.3%
|
3
75%
|
| Grade 3: White Blood Cell Low |
1
33.3%
|
0
0%
|
| Grade 3: Hemoglobin Low |
1
33.3%
|
0
0%
|
| Grade 2: Neutrophil Count Low |
2
66.7%
|
2
50%
|
| Grade 2: Lymphocyte Count Low |
1
33.3%
|
1
25%
|
| Grade 3: Lymphocyte Count Low |
1
33.3%
|
0
0%
|
| Grade 2: Glucose High |
2
66.7%
|
2
50%
|
| Grade 3: Bilirubin Total High |
0
0%
|
1
25%
|
| Grade 2: AST (GOT) High |
1
33.3%
|
0
0%
|
| Grade 2: Gamma-glutamyl Transferase (GGT) High |
2
66.7%
|
0
0%
|
| Grade 2: CK (CPK) High |
2
66.7%
|
1
25%
|
| Grade 2: Potassium Low |
1
33.3%
|
1
25%
|
| Grade 2: Corrected Calcium Low |
1
33.3%
|
0
0%
|
| Grade 2: PT- INR High |
0
0%
|
1
25%
|
| Grade 2: Triglycerides High |
1
33.3%
|
1
25%
|
| Grade 3: Triglycerides High |
0
0%
|
1
25%
|
| Title | Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters |
|---|---|
| Description | Here "BP" is blood pressure. |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 712) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 15 |
| Body Temperature <35.6 degree Celsius |
7
233.3%
|
4
100%
|
| Systolic BP >180 mmHg |
1
33.3%
|
0
0%
|
| Diastolic BP >110 mmHg |
1
33.3%
|
0
0%
|
| Diastolic BP <50 mmHg |
0
0%
|
1
25%
|
| Pulse <50 bpm |
2
66.7%
|
1
25%
|
| Title | Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters |
|---|---|
| Description | |
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 712) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety analysis set included all participants who received at least 1 dose of study drug. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 15 |
| Heart Rate <50 bpm |
4
133.3%
|
2
50%
|
| QT Interval >=460 msec |
5
166.7%
|
4
100%
|
| QTcF Interval >=500 msec |
2
66.7%
|
5
125%
|
| Title | Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28 |
|---|---|
| Description | |
| Time Frame | Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 3 | 3 | 3 |
| Day 1 |
191.7
(94.405)
|
198.0
(62.386)
|
250.0
(207.56)
|
254.0
(330.58)
|
| Day 14 |
23.53
(1.4189)
|
94.40
(115.08)
|
216.1
(151.78)
|
65.57
(40.840)
|
| Day 28 |
38.10
(21.743)
|
34.43
(24.962)
|
94.70
(114.98)
|
25.56
(16.275)
|
| Title | Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28 |
|---|---|
| Description | |
| Time Frame | Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 3 | 3 | 3 |
| Day 1 |
679.7
(96.340)
|
933.0
(604.30)
|
761.7
(249.78)
|
663.3
(501.85)
|
| Day 14 |
199.0
(49.487)
|
363.8
(291.00)
|
741.7
(385.96)
|
379.0
(199.65)
|
| Day 28 |
239.0
(75.020)
|
323.4
(230.40)
|
469.0
(458.21)
|
227.5
(138.37)
|
| Title | Part A: Serum Testosterone Concentrations for TAK-385 |
|---|---|
| Description | |
| Time Frame | Up to Day 35 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available. |
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. |
| Measure Participants | 3 | 4 | 3 | 3 |
| Baseline |
5.440
(1.6829)
|
6.505
(2.6175)
|
6.317
(1.7503)
|
7.853
(1.1885)
|
| Day 2 |
0.603
(0.1457)
|
0.977
(0.5288)
|
0.777
(0.2485)
|
1.477
(1.3540)
|
| Day 3 |
0.350
(0.0917)
|
0.460
(0.1852)
|
0.483
(0.1762)
|
0.623
(0.3232)
|
| Day 7 |
0.283
(0.0764)
|
0.380
(0.2177)
|
0.377
(0.1332)
|
0.337
(0.0416)
|
| Day 14 |
0.140
(0.0173)
|
0.213
(0.1102)
|
0.213
(0.1012)
|
0.203
(0.0379)
|
| Day 21 |
0.143
(0.0635)
|
0.220
(0.1044)
|
0.207
(0.0635)
|
0.207
(0.0666)
|
| Day 28 |
0.137
(0.0577)
|
0.200
(0.0700)
|
0.190
(0.0693)
|
0.243
(0.0802)
|
| Day 31 |
0.137
(0.0416)
|
0.217
(0.1002)
|
0.170
(0.0436)
|
0.210
(0.0854)
|
| Day 35 |
0.130
(0.0436)
|
0.290
(0.2433)
|
0.153
(0.0321)
|
0.167
(0.0473)
|
| Title | Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF) |
|---|---|
| Description | |
| Time Frame | Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 15 |
| Mean (Standard Deviation) [percent change] |
-89.77
(13.886)
|
-93.91
(5.161)
|
| Title | Part B: Plasma Concentration of Unchanged TAK-385 |
|---|---|
| Description | |
| Time Frame | Up to Week 49 Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 14 |
| Week 1 Day 1 |
0.000
(0.0000)
|
0.000
(0.0000)
|
| Week 1 Day 1: 2 hours postdose |
72.89
(123.81)
|
88.58
(124.65)
|
| Week 1 Day 2 |
6.406
(6.0223)
|
9.854
(7.4824)
|
| Week 1 Day 4 |
4.683
(2.7897)
|
7.565
(5.0412)
|
| Week 2 Day 1 |
3.972
(1.7426)
|
8.146
(5.3370)
|
| Week 3 Day 1 |
4.123
(2.2959)
|
8.618
(6.8455)
|
| Week 5 Day 1 |
4.122
(1.8301)
|
9.105
(6.6634)
|
| Week 5 Day 1: 2 hours postdose |
20.90
(19.603)
|
30.82
(35.770)
|
| Week 9 Day 1 |
4.076
(2.1577)
|
9.496
(6.6435)
|
| Week 13 Day 1 |
4.239
(2.2374)
|
9.820
(7.2860)
|
| Week 17 Day 1 |
4.759
(2.9601)
|
9.269
(6.2961)
|
| Week 21 Day 1 |
4.254
(2.0265)
|
11.08
(10.873)
|
| Week 25 Day 1 |
5.592
(3.2911)
|
11.95
(11.792)
|
| Week 37 Day 1 |
4.924
(3.7682)
|
11.32
(10.759)
|
| Week 49 Day 1 |
4.683
(3.1686)
|
10.08
(8.1482)
|
| Title | Part B: Serum Testosterone Concentrations for TAK-385 |
|---|---|
| Description | |
| Time Frame | Up to Week 97 Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available. |
| Arm/Group Title | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg |
|---|---|---|
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. |
| Measure Participants | 15 | 15 |
| Baseline |
6.367
(1.9930)
|
7.243
(2.2424)
|
| Week 1 Day 2 |
0.975
(0.5247)
|
0.867
(0.5835)
|
| Week 1 Day 4 |
0.384
(0.0968)
|
0.463
(0.2313)
|
| Week 2 Day 1 |
0.285
(0.0741)
|
0.318
(0.1165)
|
| Week 3 Day 1 |
0.207
(0.0580)
|
0.235
(0.0925)
|
| Week 5 Day 1 |
0.213
(0.0701)
|
0.190
(0.0670)
|
| Week 9 Day 1 |
0.195
(0.0554)
|
0.191
(0.0818)
|
| Week 13 Day 1 |
0.209
(0.0746)
|
0.181
(0.0631)
|
| Week 17 Day 1 |
0.217
(0.0757)
|
0.175
(0.0548)
|
| Week 21 Day 1 |
0.222
(0.0844)
|
0.179
(0.0794)
|
| Week 25 Day 1 |
0.218
(0.0816)
|
0.202
(0.1069)
|
| Week 37 Day 1 |
0.229
(0.1046)
|
0.208
(0.1177)
|
| Week 49 Day 1 |
0.228
(0.0922)
|
0.196
(0.0849)
|
| Week 61 Day 1 |
0.204
(0.0823)
|
0.212
(0.1111)
|
| Week 73 Day 1 |
0.218
(0.0974)
|
0.203
(0.1206)
|
| Week 85 Day 1 |
0.253
(0.0878)
|
0.259
(0.1358)
|
| Week 97 Day 1 |
0.283
(0.1364)
|
0.311
(0.1792)
|
Adverse Events
| Time Frame | From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. | |||||||||||
| Arm/Group Title | Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | ||||||
| Arm/Group Description | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672. | ||||||
All Cause Mortality |
||||||||||||
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 0/15 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 3/15 (20%) | 3/15 (20%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Gastrointestinal haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Inguinal hernia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Jaundice cholestatic | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Infections and infestations | ||||||||||||
| Appendicitis perforated | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Postoperative wound infection | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Oesophageal carcinoma | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Cerebral infarction | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Product Issues | ||||||||||||
| Device loosening | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Hydronephrosis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg | Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg | Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg | Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg | Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 2/4 (50%) | 3/3 (100%) | 2/3 (66.7%) | 15/15 (100%) | 15/15 (100%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Cardiac disorders | ||||||||||||
| Atrial fibrillation | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Bradycardia | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 0/15 (0%) | ||||||
| Arrhythmia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Bundle branch block left | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Bundle branch block right | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Eye disorders | ||||||||||||
| Astigmatism | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Cataract | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Dry eye | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Retinal haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Constipation | 2/3 (66.7%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 4/15 (26.7%) | ||||||
| Diarrhoea | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 3/15 (20%) | 5/15 (33.3%) | ||||||
| Dental caries | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Nausea | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Vomiting | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Chronic gastritis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Diverticulum intestinal | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Dry mouth | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Gastrointestinal haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Haematochezia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Haemorrhoids | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Mouth haemorrhage | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Proctalgia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| General disorders | ||||||||||||
| Malaise | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Asthenia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Chest pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Hangover | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Non-cardiac chest pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Oedema peripheral | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Hepatic function abnormal | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Cholelithiasis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Hepatic steatosis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Immune system disorders | ||||||||||||
| Allergy to arthropod sting | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Seasonal allergy | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Infections and infestations | ||||||||||||
| Conjunctivitis | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 0/15 (0%) | ||||||
| Dermatophytosis of nail | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/15 (0%) | 0/15 (0%) | ||||||
| Viral upper respiratory tract infection | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/15 (0%) | 0/15 (0%) | ||||||
| Tinea manuum | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/15 (0%) | 0/15 (0%) | ||||||
| Viral upper respiratory tract infection | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 5/15 (33.3%) | 5/15 (33.3%) | ||||||
| Cystitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 2/15 (13.3%) | 0/15 (0%) | ||||||
| Bronchitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Enterocolitis bacterial | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Gingivitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Infected dermal cyst | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Influenza | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Periodontitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Pharyngitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Pneumonia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Postoperative wound infection | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Upper respiratory tract infection | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Procedural pain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Arthropod bite | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Chillblains | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Ligament sprain | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Meniscus injury | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Thermal burn | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Vaccination complication | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 1/3 (33.3%) | 1/4 (25%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| White blood cell count decreased | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Aspartate aminotransferase increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 3/15 (20%) | ||||||
| Blood cholesterol increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Weight increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 3/15 (20%) | ||||||
| Blood pressure increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Liver function test increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Blood alkaline phosphatase increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Blood thyroid stimulating hormone increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Bone density decreased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Electrocardiogram QT prolonged | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Electrocardiogram ST segment elevation | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Gamma-glutamyltransferase increased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Occult blood | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Platelet count decreased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Diabetes mellitus | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Dyslipidaemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Hypertriglyceridaemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Hypoglycaemia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Musculoskeletal pain | 0/3 (0%) | 1/4 (25%) | 1/3 (33.3%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Arthralgia | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Back pain | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Muscular weakness | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Intervertebral disc protrusion | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Lumbar spinal stenosis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Muscle spasms | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Musculoskeletal stiffness | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Myalgia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Osteoarthritis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Pain in extremity | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Periarthritis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Tendonitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Colon adenoma | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Haemangioma of liver | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Dizziness | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Dyskinesia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Neuralgia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Somnolence | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Insomnia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/15 (0%) | 0/15 (0%) | ||||||
| Anxiety | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Libido decreased | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Listless | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Pollakiuria | 0/3 (0%) | 0/4 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Dysuria | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Haematuria | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Nocturia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 1/15 (6.7%) | ||||||
| Nephrolithiasis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Proteinuria | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Gynaecomastia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Benign prostatic hyperplasia | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Scrotal mass | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Scrotal oedema | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Chronic obstructive pulmonary disease | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Emphysema | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Epistaxis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Pharyngeal inflammation | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Rhinorrhoea | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Eczema | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 2/15 (13.3%) | ||||||
| Drug eruption | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 2/15 (13.3%) | ||||||
| Cold sweat | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Dermatitis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Eczema asteatotic | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Hyperkeratosis | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 1/15 (6.7%) | ||||||
| Toxic skin eruption | 0/3 (0%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 1/15 (6.7%) | 0/15 (0%) | ||||||
| Vascular disorders | ||||||||||||
| Hot flush | 2/3 (66.7%) | 0/4 (0%) | 0/3 (0%) | 2/3 (66.7%) | 6/15 (40%) | 9/15 (60%) | ||||||
| Hypertension | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 2/15 (13.3%) | 1/15 (6.7%) | ||||||
| Hypotension | 1/3 (33.3%) | 0/4 (0%) | 0/3 (0%) | 0/3 (0%) | 0/15 (0%) | 0/15 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT02141659
Other Study ID Numbers:
- TAK-385/TB-AK160108
- U1111-1156-6034
First Posted:
May 19, 2014
Last Update Posted:
Nov 19, 2018
Last Verified:
Apr 1, 2018