Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects | NCT03687684

NCT03687684

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
U1111-1219-2623	Other Identifier	WHO
JapicCTI-184127	Registry Identifier	JapicCTI

Status Module

Name	Class
Takeda	INDUSTRY

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Japanese Cohort 1-A; TAK-831 100 mg + TAK-831 300 mg	Experimental	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
Japanese Cohort 1-B; TAK-831 100 mg + Placebo	Experimental	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 Drug: Placebo
Japanese Cohort 1-C; Placebo + TAK-831 300 mg	Experimental	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 Drug: Placebo
Japanese Cohort 2; TAK-831 300 mg	Experimental	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 Drug: Placebo
Chinese Cohort 3; TAK-831 600 mg	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAK-831	Drug	TAK-831 Tablets.	Chinese Cohort 3; TAK-831 600 mg Japanese Cohort 1-A; TAK-831 100 mg + TAK-831 300 mg Japanese Cohort 1-B; TAK-831 100 mg + Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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
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
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 Outcomes

Measure	Description	Time Frame
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
Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
The participant must be willing and able to comply with all study procedures and restrictions.
The participant must be male or female (of nonchildbearing potential) aged 20 to 55 years, inclusive, at the Screening.
The participant must have a body mass index (BMI) >=18.5 kg/m^2 and =<25.0 kg/m^2 at the Screening.
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.
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).
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).
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.
The participant must meet the birth control requirements.

Exclusion Criteria:

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.
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.
The participant is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor.
The participant has a history of cancer (malignancy).
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.
The participant has a positive alcohol or drug or immunological screen.
The participant is of childbearing potential or lactating.
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.
The participant with any gastrointestinal (GI) surgery that could impact upon the absorption of study drug.
The participant has a known hypersensitivity to any component of the formulation of TAK-831 or related compounds.
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.
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).
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.
The participant has a history of drug abuse.
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.

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Hospital Tokyo		Shinjuku-ku	Tokyo		Japan

Arm/Group Information

ID	Title	Description
FG000	Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg	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.
FG001	Japanese Cohort 1-B: TAK-831 100 mg + Placebo	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.
FG002	Japanese Cohort 1-C: Placebo + TAK-831 300 mg	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.
FG003	Japanese Cohort 2, 4 and 5: Pooled Placebo	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
FG004	Japanese Cohort 2: TAK-831 300 mg	TAK-831 300 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
FG005	Japanese Cohort 4: TAK-831 600 mg	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
FG006	Japanese Cohort 5: TAK-831 50 mg	TAK-831 50 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Japanese participants.
FG007	Chinese Cohort 3: Placebo	TAK-831 matching placebo, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.
FG008	Chinese Cohort 3: TAK-831 600 mg	TAK-831 600 mg, tablet, orally, once on Day 1 and once daily from Day 4 to Day 17 in healthy Chinese participants.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg	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.
BG001	Japanese Cohort 1-B: TAK-831 100 mg + Placebo

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)

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

Posted

Count of Participants

Participants

Cohort 1: Baseline up to Day 23; Cohorts 2-5: Baseline up to Day 31

ID	Title	Description
OG000	Japanese Cohort 1: Placebo	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.
OG001	Japanese Cohort 1: TAK-831 100 mg	TAK-831 100 mg, tablet, orally, once on Day 1 of Part 1 in healthy Japanese participants.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Japanese Cohort 1: Placebo	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 26, 2019	Jun 5, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jun 27, 2019	Jun 5, 2020	SAP_001.pdf