Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects

• Sponsor: Neurocrine Biosciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03687684
• Collaborator: Takeda (Industry)
• Enrollment: 40
• Location: 1
• Arms: 7
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: TAK-831; Drug: Placebo	Phase 1

Detailed Description

The drug being tested in this study is called TAK-831. This study will assess the safety, tolerability, pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants (Japanese and Chinese participants).

The study will enroll approximately 40 participants and include up to 5 cohorts of healthy adult Japanese or Chinese participants as following (8 participants per a cohort). Cohorts 3, 4 and 5 are optional and will be decided to run based on the data of Cohorts 1 and 2. Dose level for these cohorts will be defined based on the result of Cohort 1 or Cohort 2.

• Japanese Cohort 1-A; TAK-831 100 mg single dose + TAK-831 300 mg single dose

• Japanese Cohort 1-B; TAK-831 100 mg single dose + Placebo single dose

• Japanese Cohort 1-C; Placebo single dose + TAK-831 300 mg single dose

• Japanese Cohort 2; TAK-831 300 mg or TAK-831 matching placebo, single dose + TAK-831 300 mg or TAK-831 matching placebo, multiple dose *

• Chinese Cohort 3; TAK-831 600 mg or TAK-831 matching placebo, single dose + TAK-831 600 mg or TAK-831 matching placebo, multiple dose

• Japanese Cohort 4; TAK-831 600 mg or TAK-831 matching placebo, single dose + TAK-831 600 mg or TAK-831 matching placebo, multiple dose

• Japanese Cohort 5; TAK-831 50 mg or TAK-831 matching placebo, single dose + TAK-831 50 mg or TAK-831 matching placebo, multiple dose *The dose in Cohort 2 will be adjusted based on the safety and tolerability as well as PK and PD in Cohort 1.

Above all treatment, randomization information will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need) and TAK-831 will be administered orally.

This single center trial will be conducted in Japan. The overall time to participate in Cohort 1 of this study is approximately 12 days and 19 days in Cohorts 2 to 5. 11 days (for Cohort 1) or 12 days (for Cohorts 2 to 5) after last dose of study drug, participants will be contacted by telephone for a follow-up assessment unless abnormal, clinically significant findings are observed upon discharge.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK 831 in Healthy Adult Asian Subjects
• Actual Study Start Date: Oct 9, 2018
• Actual Primary Completion Date: Jun 9, 2019
• Actual Study Completion Date: Jun 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Japanese Cohort 1-A; TAK-831 100 mg + TAK-831 300 mg TAK-831 100 milligrams (mg), tablets, orally, once daily on Day 1, followed by TAK-831 300 mg, tablets, orally, once daily on Day 9 in healthy Japanese participants.	Drug: TAK-831; TAK-831 Tablets.
Experimental: Japanese Cohort 1-B; TAK-831 100 mg + Placebo TAK-831 100 mg, tablets, orally, once daily on Day 1 followed by TAK-831 matching placebo, tablets, orally, once daily on Day 9 in healthy Japanese participants.	Drug: TAK-831; TAK-831 Tablets.; Drug: Placebo; TAK-831 Matching Placebo Tablets.
Experimental: Japanese Cohort 1-C; Placebo + TAK-831 300 mg TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 300 mg, tablets, orally, once daily on Day 9 in healthy Japanese participants.	Drug: TAK-831; TAK-831 Tablets.; Drug: Placebo; TAK-831 Matching Placebo Tablets.
Experimental: Japanese Cohort 2; TAK-831 300 mg TAK-831 300 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 300 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Japanese participants.	Drug: TAK-831; TAK-831 Tablets.; Drug: Placebo; TAK-831 Matching Placebo Tablets.
Experimental: Chinese Cohort 3; TAK-831 600 mg TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Chinese participants. This cohort is optional and will be decided to run based on the data of Cohorts 1 and 2. The dose will be defined based on the result of Cohort 1 or Cohort 2.	Drug: TAK-831; TAK-831 Tablets.; Drug: Placebo; TAK-831 Matching Placebo Tablets.
Experimental: Japanese Cohort 4; TAK-831 600 mg TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 600 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Japanese participants. This cohort is optional and will be decided to run based on the data of Cohorts 1 and 2. The dose will be defined based on the result of Cohort 1 or Cohort 2.	Drug: TAK-831; TAK-831 Tablets.; Drug: Placebo; TAK-831 Matching Placebo Tablets.
Experimental: Japanese Cohort 5; TAK-831 TAK-831 50 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 50 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 17 in healthy Japanese participants.	Drug: TAK-831; TAK-831 Tablets.; Drug: Placebo; TAK-831 Matching Placebo Tablets.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) [Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31]

2. Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results [Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31]

3. Number of Participants Reporting at Least One TEAE Related to Vital Sign [Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31]

4. Number of Participants Reporting at Least One TEAE Related to Body Weight [Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31]

5. Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters [Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31]

Secondary Outcome Measures

1. Cmax: Maximum Observed Plasma Concentration for TAK-831 [Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose]

2. Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831 [Day 17 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post-dose]

3. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 [Cohort 1: Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Day 17 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post-dose]

4. AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831 [Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose]

5. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 [Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose]

6. Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831 [Day 1: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 17: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The participant must understand the study procedures and agree to participate by providing written informed consent (for Chinese participants, an interpreter should be present as necessary).

2. The participant must be willing and able to comply with all study procedures and restrictions.

3. The participant must be male or female (of nonchildbearing potential) aged 20 to 55 years, inclusive, at the Screening.

4. The participant must have a body mass index (BMI) >=18.5 kg/m^{2 and =<25.0 kg/m}2 at the Screening.

5. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (e.g., nicotine patch) for at least 6 months prior to the Screening.

6. Chinese participants are defined as participants who were born in mainland China, and their biological parents and grandparents must all have been of Chinese origin (for Cohort 3 only).

7. Chinese participants who have lived out of China for more than 5 years must not have significantly modified their diets since leaving China (for Cohort 3 only).

8. The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory tests, medical history, full physical examination, 12-lead electrocardiogram, and vital sign measurements performed at the Screening and prior to the first dose of study drug.

9. The participant must meet the birth control requirements.

Exclusion Criteria:

1. The participant has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary, or presents with major neurological (including stroke and chronic seizures) abnormalities or diseases.

2. The participant has participated in another investigational trial within 4 weeks before the pretrial visit (Screening). The 4-week window will be derived from the date of the last trial procedure and/or adverse event (AE) related to the trial procedure in the previous trial to the Screening Visit of the current trial.

3. The participant is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor.

4. The participant has a history of cancer (malignancy).

5. The participant has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.

6. The participant has a positive alcohol or drug or immunological screen.

7. The participant is of childbearing potential or lactating.

8. The participant had major surgery, received or lost 1 unit of blood (approximately 500 milliliters [mL]) within 8 weeks prior to the first dose of study drug.

9. The participant with any gastrointestinal (GI) surgery that could impact upon the absorption of study drug.

10. The participant has a known hypersensitivity to any component of the formulation of TAK-831 or related compounds.

11. The participant is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies, beginning approximately 7 days before administration of the initial dose of trial drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit.

12. The participant 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).

13. The participant who 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.

14. The participant has a history of drug abuse.

15. The participant has a (QT interval with Fridericia's correction method) QTcF >450 milliseconds (msec) (males) or >470 msec (females) or PR outside the range of 120 to 220 msec at the Screening Visit or Check-in.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo	Japan

Sponsors and Collaborators

• Neurocrine Biosciences
• Takeda

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 26, 2019
• Statistical Analysis Plan - Jun 27, 2019

More Information

Publications

None provided.

• Responsible Party: Neurocrine Biosciences
• ClinicalTrials.gov Identifier: NCT03687684
• Other Study ID Numbers: TAK-831-1002; U1111-1219-2623; JapicCTI-184127
• First Posted: Sep 27, 2018
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at single site in Japan from 09 October 2018 to 19 June 2019.
Pre-assignment Detail	Healthy adult participants were randomized to receive TAK-831: under 3-sequential dose escalation design to the sequence of administration of A (100 mg +300 mg), B (100 mg + Placebo), and C (Placebo + 300 mg) in Cohort 1 (Japanese); single dose followed by multiple dose of TAK-831 or Placebo in Cohorts 2, 4, 5 (Japanese) and in Cohort 3 (Chinese).

Arm/Group Title	Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg	Japanese Cohort 1-B: TAK-831 100 mg + Placebo	Japanese Cohort 1-C: Placebo + TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 100 milligram (mg), tablet, orally, once on Day 1 of Part 1, followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 matching placebo, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Period Title: Overall Study
STARTED	4	2	2	6	6	6	6	2	6
COMPLETED	4	2	2	6	6	6	6	2	6
NOT COMPLETED	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg	Japanese Cohort 1-B: TAK-831 100 mg + Placebo	Japanese Cohort 1-C: Placebo + TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg	Total
Arm/Group Description	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1, followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 matching placebo, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 of Part 1 followed by TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	Total of all reporting groups
Overall Participants	4	2	2	6	6	6	6	2	6	40
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	2 100%	2 100%	6 100%	6 100%	6 100%	6 100%	2 100%	6 100%	40 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	4 100%	2 100%	2 100%	6 100%	6 100%	6 100%	6 100%	2 100%	6 100%	40 100%
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	4 100%	2 100%	2 100%	6 100%	6 100%	6 100%	6 100%	2 100%	6 100%	40 100%
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	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
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)
Japan	4 100%	2 100%	2 100%	6 100%	6 100%	6 100%	6 100%	2 100%	6 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)
Time Frame	Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Japanese Cohort 1: Placebo	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	4	6	6	6	6	6	6	2	6
Count of Participants [Participants]	0 0%	2 100%	0 0%	4 66.7%	4 66.7%	1 16.7%	2 33.3%	1 50%	2 33.3%

2. Primary Outcome

Title	Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results
Time Frame	Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Japanese Cohort 1: Placebo	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	4	6	6	6	6	6	6	6	2
Count of Participants [Participants]	0 0%	2 100%	0 0%	2 33.3%	2 33.3%	1 16.7%	1 16.7%	1 50%	0 0%

3. Primary Outcome

Title	Number of Participants Reporting at Least One TEAE Related to Vital Sign
Time Frame	Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Japanese Cohort 1: Placebo	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	4	6	6	6	6	6	6	2	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants Reporting at Least One TEAE Related to Body Weight
Time Frame	Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Japanese Cohort 1: Placebo	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	4	6	6	6	6	6	6	2	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

5. Primary Outcome

Title	Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters
Time Frame	Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who received at least one dose of study drug.

Arm/Group Title	Japanese Cohort 1: Placebo	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2, 4 and 5: Pooled Placebo	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: Placebo	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	4	6	6	6	6	6	6	2	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Cmax: Maximum Observed Plasma Concentration for TAK-831
Time Frame	Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose

Outcome Measure Data

Analysis Population Description

The pharmacokinetic (PK) analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.

Arm/Group Title	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	6	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)]	985.5 (20.8)	1823 (53.7)	981.7 (29.1)	1602 (42.1)	339.9 (33.3)	1807 (28.5)

7. Secondary Outcome

Title	Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831
Time Frame	Day 17 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.

Arm/Group Title	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	831.8 (29.1)	1903 (33.6)	417.0 (23.8)	1581 (42.4)

8. Secondary Outcome

Title	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
Time Frame	Cohort 1: Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72 hours post-dose; Day 17 pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.

Arm/Group Title	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	6	6	6	6	6	6
Day 1	0.5000	0.5000	2.000	1.750	0.5000	1.500
Day 17	NA	NA	1.750	2.000	0.5000	2.000

9. Secondary Outcome

Title	AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831
Time Frame	Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.

Arm/Group Title	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	6	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [hour*nanogram per milliliter(h*ng/mL)]	1553 (11.8)	3630 (11.9)	3700 (32.2)	6477 (26.2)	847.4 (21.5)	5504 (22.3)

10. Secondary Outcome

Title	AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Time Frame	Cohort 1: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose; Cohorts 2 to 5: Day 1 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.

Arm/Group Title	Japanese Cohort 1: TAK-831 100 mg	Japanese Cohort 1: TAK-831 300 mg	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	6	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	1581 (11.7)	3653 (12.2)	3730 (31.9)	6518 (26.2)	923.6 (22.1)	5530 (22.3)

11. Secondary Outcome

Title	Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831
Time Frame	Day 1: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 17: pre-dose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose

Outcome Measure Data

Analysis Population Description

The PK analysis set included participants who received at least one dose of study drug, and who were appropriately evaluable for at least 1 PK parameter.

Arm/Group Title	Japanese Cohort 2: TAK-831 300 mg	Japanese Cohort 4: TAK-831 600 mg	Japanese Cohort 5: TAK-831 50 mg	Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
Measure Participants	6	6	6	6
Day 1	3576 (30.6)	6211 (26.8)	794.5 (22.2)	5340 (22.3)
Day 17	2738 (31.1)	8237 (28.4)	983.0 (22.3)	5839 (21.6)

Adverse Events

Time Frame	Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 23 in Cohort 1 and up to Day 31 in Cohorts 2 to 5
Arm/Group Title	Japanese Cohort 1: Placebo		Japanese Cohort 1: TAK-831 100 mg		Japanese Cohort 1: TAK-831 300 mg		Japanese Cohort 2, 4 and 5: Pooled Placebo		Japanese Cohort 2: TAK-831 300 mg		Japanese Cohort 4: TAK-831 600 mg		Japanese Cohort 5: TAK-831 50 mg		Chinese Cohort 3: Placebo		Chinese Cohort 3: TAK-831 600 mg
Arm/Group Description	TAK-831 matching placebo, tablets, orally, once on Day 1 of Part 1 and Day 1 (Day 9) of Part 2 in healthy Japanese participants.		TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.		TAK-831 300 mg, tablet, orally, once on Day 1 (Day 9) of Part 2 in healthy Japanese participants.		TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.		TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.		TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.		TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.		TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.		TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
All Cause Mortality
	Japanese Cohort 1: Placebo		Japanese Cohort 1: TAK-831 100 mg		Japanese Cohort 1: TAK-831 300 mg		Japanese Cohort 2, 4 and 5: Pooled Placebo		Japanese Cohort 2: TAK-831 300 mg		Japanese Cohort 4: TAK-831 600 mg		Japanese Cohort 5: TAK-831 50 mg		Chinese Cohort 3: Placebo		Chinese Cohort 3: TAK-831 600 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
Total	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Serious Adverse Events
	Japanese Cohort 1: Placebo		Japanese Cohort 1: TAK-831 100 mg		Japanese Cohort 1: TAK-831 300 mg		Japanese Cohort 2, 4 and 5: Pooled Placebo		Japanese Cohort 2: TAK-831 300 mg		Japanese Cohort 4: TAK-831 600 mg		Japanese Cohort 5: TAK-831 50 mg		Chinese Cohort 3: Placebo		Chinese Cohort 3: TAK-831 600 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
Total	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Japanese Cohort 1: Placebo		Japanese Cohort 1: TAK-831 100 mg		Japanese Cohort 1: TAK-831 300 mg		Japanese Cohort 2, 4 and 5: Pooled Placebo		Japanese Cohort 2: TAK-831 300 mg		Japanese Cohort 4: TAK-831 600 mg		Japanese Cohort 5: TAK-831 50 mg		Chinese Cohort 3: Placebo		Chinese Cohort 3: TAK-831 600 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
Total	0/4 (0%)		2/6 (33.3%)		0/6 (0%)		4/6 (66.7%)		4/6 (66.7%)		1/6 (16.7%)		2/6 (33.3%)		1/2 (50%)		2/6 (33.3%)
Cardiac disorders
Tachycardia	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
Post lumbar puncture syndrome	0/4 (0%)		0/6 (0%)		0/6 (0%)		2/6 (33.3%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Procedural headache	0/4 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		1/6 (16.7%)
Vascular procedure complication	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/2 (0%)		1/6 (16.7%)
Investigations
Blood creatine phosphokinase increased	0/4 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Protein urine present	0/4 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Alanine aminotransferase increased	0/4 (0%)		0/6 (0%)		0/6 (0%)		2/6 (33.3%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/2 (0%)		0/6 (0%)
Blood pressure systolic increased	0/4 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Red blood cells urine positive	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
White blood cells urine positive	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Blood urine present	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/2 (50%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
Pain in extremity	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		1/6 (16.7%)
Skin and subcutaneous tissue disorders
Papule	0/4 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)
Vascular disorders
Hot flush	0/4 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/2 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Generally, the PI may publish results of the study following the publication of results by the Sponsor.