CompletedNCT03687684Updated Jun 14, 2021Results posted

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

A Phase 1 interventional study of TAK-831 and Placebo in Healthy Volunteers, sponsored by Neurocrine Biosciences. Completed at 1 site in Japan. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Neurocrine Biosciences · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 20 Years to 55 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

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
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo

Interventions

DrugTAK-831
TAK-831 Tablets.
DrugPlacebo
TAK-831 Matching Placebo Tablets.

What researchers measure

Primary outcomes

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
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
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
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
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

Secondary outcomes

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
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
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
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
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
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

Results

Posted Jun 29, 2020

Participant flow

Participants took part in the study at single site in Japan from 09 October 2018 to 19 June 2019.

Participant flow — Overall Study
Milestone	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
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

Outcome measures

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)
Participants	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
Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE)	0	2	0	4	4	1	2	1	2

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results
Participants	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
Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results	0	2	0	2	2	1	1	1	0

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Reporting at Least One TEAE Related to Vital Sign
Participants	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
Number of Participants Reporting at Least One TEAE Related to Vital Sign	0	0	0	1	1	0	0	0	0

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Reporting at Least One TEAE Related to Body Weight
Participants	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
Number of Participants Reporting at Least One TEAE Related to Body Weight	0	0	0	0	0	0	0	0	0

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters
Participants	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
Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters	0	0	0	0	0	0	0	0	0

SecondaryCmax: 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
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Cmax: Maximum Observed Plasma Concentration for TAK-831
nanogram per milliliter (ng/mL)	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
Cmax: Maximum Observed Plasma Concentration for TAK-831	985.5 ± 20.8	1823 ± 53.7	981.7 ± 29.1	1602 ± 42.1	339.9 ± 33.3	1807 ± 28.5

SecondaryCohorts 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
Reported as:: Geometric mean · ng/mL

Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831
ng/mL	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
Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831	831.8 ± 29.1	1903 ± 33.6	417.0 ± 23.8	1581 ± 42.4

SecondaryTmax: 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
Reported as:: Median · hour

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
hour	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
Day 1	0.5000 (0.500 to 0.500)	0.5000 (0.500 to 1.00)	2.000 (1.50 to 4.00)	1.750 (1.50 to 4.00)	0.5000 (0.500 to 1.50)	1.500 (1.50 to 2.00)
Day 17	NA (NA to NA)	NA (NA to NA)	1.750 (1.00 to 4.000)	2.000 (1.00 to 4.00)	0.5000 (0.500 to 2.00)	2.000 (1.50 to 2.00)

SecondaryAUClast: 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
Reported as:: Geometric mean · hour*nanogram per milliliter(h*ng/mL)

AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831
hournanogram per milliliter(hng/mL)	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
AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831	1553 ± 11.8	3630 ± 11.9	3700 ± 32.2	6477 ± 26.2	847.4 ± 21.5	5504 ± 22.3

SecondaryAUC∞: 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
Reported as:: Geometric mean · h*ng/mL

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
h*ng/mL	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
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831	1581 ± 11.7	3653 ± 12.2	3730 ± 31.9	6518 ± 26.2	923.6 ± 22.1	5530 ± 22.3

SecondaryCohorts 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
Reported as:: Geometric mean · h*ng/mL

Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831
h*ng/mL	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
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

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Japanese Cohort 1: Placebo	0/4 (0%)	0/4 (0%)	0/4 (0%)
Japanese Cohort 1: TAK-831 100 mg	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
Japanese Cohort 1: TAK-831 300 mg	0/6 (0%)	0/6 (0%)	0/6 (0%)
Japanese Cohort 2, 4 and 5: Pooled Placebo	0/6 (0%)	0/6 (0%)	4/6 (66.7%)
Japanese Cohort 2: TAK-831 300 mg	0/6 (0%)	0/6 (0%)	4/6 (66.7%)
Japanese Cohort 4: TAK-831 600 mg	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
Japanese Cohort 5: TAK-831 50 mg	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
Chinese Cohort 3: Placebo	0/2 (0%)	0/2 (0%)	1/2 (50%)
Chinese Cohort 3: TAK-831 600 mg	0/6 (0%)	0/6 (0%)	2/6 (33.3%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	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
Blood urine presentInvestigations	0/4	0/6	0/6	0/6	0/6	0/6	0/6	1/2	0/6
Post lumbar puncture syndromeInjury, poisoning and procedural complications	0/4	0/6	0/6	2/6	1/6	0/6	0/6	0/2	0/6
Alanine aminotransferase increasedInvestigations	0/4	0/6	0/6	2/6	0/6	1/6	1/6	0/2	0/6
Blood creatine phosphokinase increasedInvestigations	0/4	1/6	0/6	1/6	0/6	0/6	0/6	0/2	0/6
Protein urine presentInvestigations	0/4	1/6	0/6	0/6	1/6	0/6	0/6	0/2	0/6
TachycardiaCardiac disorders	0/4	0/6	0/6	0/6	1/6	0/6	0/6	0/2	0/6
Procedural headacheInjury, poisoning and procedural complications	0/4	0/6	0/6	1/6	1/6	0/6	0/6	0/2	1/6
Vascular procedure complicationInjury, poisoning and procedural complications	0/4	0/6	0/6	0/6	0/6	0/6	1/6	0/2	1/6
Blood pressure systolic increasedInvestigations	0/4	0/6	0/6	1/6	0/6	0/6	0/6	0/2	0/6
Red blood cells urine positiveInvestigations	0/4	0/6	0/6	0/6	1/6	0/6	0/6	0/2	0/6

Baseline characteristics

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

Age, Categorical
Age, Categorical(Participants)	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
<=18 years	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	4	2	2	6	6	6	6	2	6	40
>=65 years	0	0	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	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
Female	0	0	0	0	0	0	0	0	0	0
Male	4	2	2	6	6	6	6	2	6	40

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	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
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0
Asian	4	2	2	6	6	6	6	2	6	40
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0	0	0	0
White	0	0	0	0	0	0	0	0	0	0
More than one race	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	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
Japan	4	2	2	6	6	6	6	2	6	40

Study locations

1 site

Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan

References and documents

Study documents

Study protocol · Feb 26, 2019
Statistical analysis plan · Jun 27, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03687684
Lead sponsor: Neurocrine Biosciences
Collaborators: Takeda
Responsible party: Sponsor
First posted: Sep 27, 2018
Start date: Oct 9, 2018
Primary completion: Jun 9, 2019
Completion: Jun 19, 2019
Results posted: Jun 29, 2020
Last update: Jun 14, 2021

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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