A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants
Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03501069
Collaborator
(none)
32
2
6
6.9
16
2.3
Study Details
Study Description
Brief Summary
The purpose of this study is to characterize safety and tolerability of TAK-418 in non-Japanese and Japanese healthy female participants when administered at single or multiple (once daily [QD]) oral doses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The drug being tested in this study is called TAK-418. This study will assess the safety, tolerability, PK and PD of single and multiple rising doses of TAK-418 in healthy Japanese or non-Japanese females.
The study will enroll approximately 48 participants in 6 cohorts and each cohort will have 8 participants. The study will include 2 parts: single rising dose (SRD) in Cohort 1 and multiple rising dose (MRD) in Cohorts 2 to 6. Cohort 3 will include cerebrospinal fluid (CSF) collection. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 6 cohorts.
This two-center trial will be conducted in the United States. The overall time to participate in Cohort 1 of this study is approximately 105 days and 98 days in Cohort 2. Participants will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-418 in Healthy Female Subjects
Actual Study Start Date
:
May 30, 2018
Actual Primary Completion Date
:
Dec 26, 2018
Actual Study Completion Date
:
Dec 26, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Non-Japanese Cohort 1: TAK-418 120 mg and TAK-418 160 mg TAK-418 120 milligram (mg) or TAK-418 matching placebo, capsule, orally, once on Day 1 of Period A followed by a minimum of 14 days of washout period, followed by TAK-418 160 mg or TAK-418 matching placebo, capsule, orally, once on Day 1 of Period B. The actual TAK-418 dose for Period B will be determined based on safety, tolerability, and PK data available from the previous dose in Period A. |
Drug: TAK-418
TAK-418 capsules.
Drug: TAK-418 Matching Placebo
TAK-418 matching placebo capsules.
|
| Experimental: Non-Japanese Cohort 2: TAK-418 20 mg TAK-418 20 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. |
Drug: TAK-418
TAK-418 capsules.
Drug: TAK-418 Matching Placebo
TAK-418 matching placebo capsules.
|
| Experimental: Non-Japanese Cohort 3: TAK-418 40 mg TAK-418 40 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 3 will be determined based on safety, tolerability, and PK data available from the previous doses. |
Drug: TAK-418
TAK-418 capsules.
Drug: TAK-418 Matching Placebo
TAK-418 matching placebo capsules.
|
| Experimental: Non-Japanese Cohort 4: TAK-418 60 mg TAK-418 60 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 4 will be determined based on safety, tolerability, and PK data available from the previous doses. |
Drug: TAK-418
TAK-418 capsules.
Drug: TAK-418 Matching Placebo
TAK-418 matching placebo capsules.
|
| Experimental: Japanese Cohort 5: TAK-418 20 mg TAK-418 20 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 5 will be determined based on safety, tolerability, and PK data available from the previous doses. |
Drug: TAK-418
TAK-418 capsules.
Drug: TAK-418 Matching Placebo
TAK-418 matching placebo capsules.
|
| Experimental: Japanese Cohort 6: TAK-418 40 mg TAK-418 40 mg or TAK-418 matching placebo, capsule, orally, once daily for 10 days. The actual TAK-418 dose for Cohort 6 will be determined based on safety, tolerability, and PK data available from the previous doses. |
Drug: TAK-418
TAK-418 capsules.
Drug: TAK-418 Matching Placebo
TAK-418 matching placebo capsules.
|
Outcome Measures
Primary Outcome Measures
- Cohort 1: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAE) [Baseline up to Day 60]
- Cohorts 2 to 5: Number of Participants Who Experienced at Least One TEAEs and SAE [Baseline up to Day 70]
- Cohort 1: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose [Baseline up to Day 60]
- Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose [Baseline up to Day 70]
- Cohort 1: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose [Baseline up to Day 60]
- Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose [Baseline up to Day 70]
- Cohort 1: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose [Baseline up to Day 60]
- Cohorts 2 to 5: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead ECG Parameters at Least Once Post Dose [Baseline up to Day 70]
Secondary Outcome Measures
- Cohort 1; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418 on Day 1 [Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose]
- Cohort 2 to 5: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Over the Dosing Interval for TAK-418 on Days 1 and 10 [Days 1 and 10 pre-dose and at multiple time points (up to 24 hours) post-dose]
- Cmax: Maximum Observed Plasma Concentration for TAK-418 [Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose]
- Tmax: Time to Reach the Cmax for TAK-418 [Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Has a body mass index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the Screening Visit. (Cohorts 1 to 4 only).
-
Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the first dose of trial drug or invasive procedure.
-
The participant either is of nonchildbearing potential, OR, if of childbearing potential, is using a highly effective method of contraception with low user dependency during the entire duration of the study.
For Cohorts 5 and 6 (Japanese participants) only:
- Has a BMI >=18.0 and <= 26.0 kg/m^2, at the Screening Visit.
Exclusion Criteria:
-
Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV) antibody/antigen, at Screening.
-
Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL]) within 4 weeks before the Screening Visit.
-
Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
-
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
-
Has a substance abuse disorder.
-
Has risk of suicide according to the investigator's clinical judgment per Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or has made a suicide attempt in the 6 months before Screening.
-
Has luteinizing hormone (LH), follicle-stimulating hormone (FSH), or estradiol levels that are clinically abnormal.
-
Has a resting heart rate outside of the range of 50 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).
For Cohort 3 only (includes CSF sample collection):
-
Has had CSF collection performed within 30 days before Check-in (Day -1).
-
Has significant vertebral deformities (scoliosis or kyphosis) that, in the opinion of the investigator, may interfere with the lumbar puncture procedure.
-
Has a local infection at the puncture site.
-
Has thrombocytopenia or other suspected bleeding tendencies noted before the procedure.
-
Has developed signs and symptoms of spinal radiculopathy, including lower extremity pain and paresthesia.
-
Has any focal neurological deficit that might suggest an increase in intracranial pressure.
-
Has any abnormal finding on ophthalmological assessment/fundoscopy indicative of raised intracranial pressure (that is, optic disc swelling/edema; or [uncontrolled] hypertensive retinopathy).
-
Regularly has moderate-to-severe headaches requiring analgesics.
-
Has any bleeding abnormality or history of bleeding abnormalities.
-
Has abnormal coagulation tests (prothrombin time [PT]/international normalized ratio [INR], partial thromboplastin time [PTT]) at Screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parexel International | Glendale | California | United States | 91206 |
| 2 | PRA Health Sciences | Salt Lake City | Utah | United States | 84124 |
Sponsors and Collaborators
- Millennium Pharmaceuticals, Inc.
Investigators
- Study Director: Medical Director, Takeda
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03501069
Other Study ID Numbers:
- TAK-418-1003
- U1111-1209-4647
First Posted:
Apr 18, 2018
Last Update Posted:
Jun 16, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Millennium Pharmaceuticals, Inc.
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 2 investigative sites in the United States from 30 May 2018 to 26 December 2018. |
|---|---|
| Pre-assignment Detail | Healthy female participants were enrolled to receive TAK-418 as single rising dose (SRD) dose of 120 milligram (mg), or 160 mg (non-Japanese cohort), and/or placebo in a crossover fashion; and multiple rising dose (MRD) of 20 mg, 60 mg, 160 mg (non-Japanese cohort) or 20 mg (Japanese cohort). The study was terminated early due to business decision. |
| Arm/Group Title | Non-Japanese Cohort 1: TAK-418 120 mg + Placebo | Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg | Non-Japanese Cohort 1: Placebo + TAK-418 160 mg | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B. | TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Period Title: Period A | |||||||||
| STARTED | 2 | 4 | 2 | 5 | 1 | 6 | 6 | 3 | 3 |
| COMPLETED | 2 | 4 | 2 | 5 | 1 | 6 | 6 | 3 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period A | |||||||||
| STARTED | 2 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 2 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Period A | |||||||||
| STARTED | 2 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 2 | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Non-Japanese Cohort 1: TAK-418 120 mg + Placebo | Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg | Non-Japanese Cohort 1: Placebo + TAK-418 160 mg | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B. | TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | Total of all reporting groups |
| Overall Participants | 2 | 4 | 2 | 5 | 1 | 6 | 6 | 3 | 3 | 32 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
33.5
(7.78)
|
39.8
(11.32)
|
39.0
(18.38)
|
47.8
(11.78)
|
49.0
(NA)
|
39.2
(12.32)
|
46.7
(10.93)
|
43.3
(4.04)
|
50.3
(3.51)
|
43.4
(10.60)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
2
100%
|
4
100%
|
2
100%
|
5
100%
|
1
100%
|
6
100%
|
6
100%
|
3
100%
|
3
100%
|
32
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||
| Hispanic or Latino |
0
0%
|
1
25%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
1
16.7%
|
1
33.3%
|
0
0%
|
4
12.5%
|
| Not Hispanic or Latino |
2
100%
|
3
75%
|
2
100%
|
4
80%
|
1
100%
|
6
100%
|
5
83.3%
|
2
66.7%
|
3
100%
|
28
87.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
100%
|
0
0%
|
0
0%
|
0
0%
|
3
100%
|
4
12.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
50%
|
1
25%
|
2
100%
|
1
20%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
6
18.8%
|
| White |
1
50%
|
3
75%
|
0
0%
|
4
80%
|
0
0%
|
6
100%
|
5
83.3%
|
3
100%
|
0
0%
|
22
68.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||||||
| United States |
2
100%
|
4
100%
|
2
100%
|
5
100%
|
1
100%
|
6
100%
|
6
100%
|
3
100%
|
3
100%
|
32
100%
|
| Weight (kilogram (kg)) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [kilogram (kg)] |
71.050
(9.8288)
|
67.875
(5.5506)
|
66.250
(13.7886)
|
70.60
(7.090)
|
67.90
(NA)
|
66.60
(6.690)
|
70.22
(9.100)
|
78.27
(5.848)
|
49.60
(3.857)
|
67.859
(9.4141)
|
| Height (centimeter (cm)) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [centimeter (cm)] |
173.00
(5.657)
|
161.00
(4.243)
|
166.50
(6.364)
|
162.8
(7.85)
|
167.0
(NA)
|
164.7
(6.47)
|
163.0
(8.15)
|
172.3
(7.23)
|
154.7
(2.52)
|
164.09
(7.485)
|
| Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [kilogram per square meter (kg/m^2)] |
23.90
(4.808)
|
26.23
(2.636)
|
23.75
(3.182)
|
26.62
(1.599)
|
24.30
(NA)
|
24.53
(1.401)
|
26.42
(2.872)
|
26.47
(3.202)
|
20.77
(1.553)
|
25.16
(2.775)
|
Outcome Measures
| Title | Cohort 1: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAE) |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A. | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. |
| Measure Participants | 2 | 2 | 6 | 6 |
| TEAE |
1
50%
|
0
0%
|
3
150%
|
2
40%
|
| SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Cohorts 2 to 5: Number of Participants Who Experienced at Least One TEAEs and SAE |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 70 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 5 | 1 | 6 | 6 | 3 | 3 |
| TEAE |
3
150%
|
1
25%
|
5
250%
|
6
120%
|
3
300%
|
1
16.7%
|
| SAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Cohort 1: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A. | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. |
| Measure Participants | 2 | 2 | 6 | 6 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
1
20%
|
| Title | Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 70 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 5 | 1 | 6 | 6 | 3 | 3 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Cohort 1: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A. | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. |
| Measure Participants | 2 | 2 | 6 | 6 |
| Pulse Rate less than (<) 50 beats per minute (bpm) |
0
0%
|
1
25%
|
1
50%
|
0
0%
|
| Systolic Blood Pressure <85 mmHg |
0
0%
|
0
0%
|
0
0%
|
1
20%
|
| Temperature <35.6 Celsius (C) |
0
0%
|
1
25%
|
1
50%
|
1
20%
|
| Title | Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 70 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 5 | 1 | 6 | 6 | 3 | 3 |
| Diastolic Blood Pressure <50 mmHg |
0
0%
|
0
0%
|
0
0%
|
2
40%
|
0
0%
|
0
0%
|
| Pulse Rate greater than (>) 120 bpm |
1
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Systolic Blood Pressure <85 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
| Title | Cohort 1: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A. | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. |
| Measure Participants | 2 | 2 | 6 | 6 |
| ECG Mean Heart Rate <50 bpm |
0
0%
|
1
25%
|
0
0%
|
1
20%
|
| QT Interval >=460 millisecond (msec) |
0
0%
|
0
0%
|
1
50%
|
0
0%
|
| Title | Cohorts 2 to 5: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead ECG Parameters at Least Once Post Dose |
|---|---|
| Description | |
| Time Frame | Baseline up to Day 70 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set included all randomized participants who received at least 1 dose of study drug. |
| Arm/Group Title | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 5 | 1 | 6 | 6 | 3 | 3 |
| Count of Participants [Participants] |
1
50%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Cohort 1; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418 on Day 1 |
|---|---|
| Description | |
| Time Frame | Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic (PK) set included all participants from the safety set who had at least 1 measurable post dose plasma or cerebrospinal fluid (CSF) concentration or amount of drug in urine of TAK-418F. |
| Arm/Group Title | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg |
|---|---|---|
| Arm/Group Description | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. |
| Measure Participants | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [hour*nanogram per milliliter (hr*ng/mL)] |
3761.2
(20.8)
|
4229.0
(40.4)
|
| Title | Cohort 2 to 5: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Over the Dosing Interval for TAK-418 on Days 1 and 10 |
|---|---|
| Description | |
| Time Frame | Days 1 and 10 pre-dose and at multiple time points (up to 24 hours) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. |
| Arm/Group Title | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|
| Arm/Group Description | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 6 | 6 | 3 | 3 |
| Day 1 |
503.3
(165.71)
|
1445.5
(353.26)
|
3747.3
(239.53)
|
610.3
(87.89)
|
| Day 10 |
668.2
(228.83)
|
1660.5
(421.77)
|
4058.3
(249.49)
|
677.3
(73.66)
|
| Title | Cmax: Maximum Observed Plasma Concentration for TAK-418 |
|---|---|
| Description | |
| Time Frame | Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 6 | 6 | 6 | 6 | 3 | 3 |
| Day 1 |
714.7
(21.6)
|
750.3
(40.3)
|
81.1
(35.8)
|
270.8
(21.6)
|
657.8
(33.0)
|
154.5
(5.9)
|
| Day 10 |
113.4
(30.8)
|
303.4
(17.6)
|
692.4
(15.4)
|
171.1
(5.9)
|
| Title | Tmax: Time to Reach the Cmax for TAK-418 |
|---|---|
| Description | |
| Time Frame | Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. PK-evaluable population where data at specified time points was available. |
| Arm/Group Title | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. |
| Measure Participants | 6 | 6 | 6 | 6 | 3 | 3 |
| Day 1 |
1.500
|
1.250
|
1.750
|
1.500
|
1.500
|
1.000
|
| Day 10 |
1.260
|
1.250
|
1.000
|
1.000
|
Adverse Events
| Time Frame | TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 mg | ||||||||||
| Arm/Group Description | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A. | TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B. | TAK-418 120 mg, capsule, orally, once on Day 1 of Period A. | TAK-418 160 mg, capsule, orally, once on Day 1 of Period B. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 placebo-matching capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | TAK-418 60 mg, capsule, orally, once daily for 10 days. | TAK-418 160 mg, capsule, orally, once daily for 10 days. | TAK-418 20 mg, capsule, orally, once daily for 10 days. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Non-Japanese Cohort 1; Period A: Placebo | Non-Japanese Cohort 1; Period B: Placebo | Non-Japanese Cohort 1: TAK 418 120 mg | Non-Japanese Cohort 1: TAK 418 160 mg | Non-Japanese Cohorts 2 to 4: Pooled Placebo | Japanese Cohort 5: Placebo | Non-Japanese Cohort 2: TAK-418 20 mg | Non-Japanese Cohort 3: TAK-418 60 mg | Non-Japanese Cohort 4: TAK-418 160 mg | Japanese Cohort 5: TAK-418 20 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 | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/2 (50%) | 0/2 (0%) | 3/6 (50%) | 2/6 (33.3%) | 3/5 (60%) | 1/1 (100%) | 5/6 (83.3%) | 6/6 (100%) | 3/3 (100%) | 1/3 (33.3%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Palpitations | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/3 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Vertigo | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Tinnitus | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Nausea | 1/2 (50%) | 0/2 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 4/6 (66.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Vomiting | 1/2 (50%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 3/6 (50%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Diarrhoea | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/3 (66.7%) | 0/3 (0%) | ||||||||||
| Dry mouth | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 2/3 (66.7%) | 0/3 (0%) | ||||||||||
| Constipation | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 2/6 (33.3%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Abdominal pain | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Dyspepsia | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 1/3 (33.3%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Fatigue | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Feeling abnormal | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Gastroenteritis | 0/2 (0%) | 0/2 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Gastroenteritis viral | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Nasopharyngitis | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Upper respiratory tract infection | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Skin abrasion | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Arthropod bite | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Procedural headache | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Decreased appetite | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Food aversion | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Myalgia | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 2/6 (33.3%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Back pain | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Flank pain | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/3 (0%) | ||||||||||
| Muscle spasms | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Musculoskeletal stiffness | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Pain in extremity | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Dizziness | 0/2 (0%) | 0/2 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Headache | 0/2 (0%) | 0/2 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/5 (20%) | 1/1 (100%) | 4/6 (66.7%) | 5/6 (83.3%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Somnolence | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 2/6 (33.3%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Anxiety | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Depressed mood | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Hypervigilance | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Insomnia | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/1 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Bradyphrenia | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Hyperhidrosis | 0/2 (0%) | 0/2 (0%) | 0/6 (0%) | 0/6 (0%) | 1/5 (20%) | 0/1 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/3 (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:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT03501069
Other Study ID Numbers:
- TAK-418-1003
- U1111-1209-4647
First Posted:
Apr 18, 2018
Last Update Posted:
Jun 16, 2020
Last Verified:
Jun 1, 2020