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

NCT03687684 | Completed Phase 1 Results

• 3 other identifiers: TAK-831-1002U1111-1219-2623JapicCTI-184127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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 (6)

• 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

  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

  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

  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

  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

Study Arms (7)

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

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

Japanese Cohort 4; TAK-831 600 mg

EXPERIMENTAL

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

Japanese Cohort 5; TAK-831

EXPERIMENTAL

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

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; Japanese Cohort 1-C; Placebo + TAK-831 300 mg; Japanese Cohort 2; TAK-831 300 mg; Japanese Cohort 4; TAK-831 600 mg; Japanese Cohort 5; TAK-831

Placebo DRUG

TAK-831 Matching Placebo Tablets.

Chinese Cohort 3; TAK-831 600 mg; Japanese Cohort 1-B; TAK-831 100 mg + Placebo; Japanese Cohort 1-C; Placebo + TAK-831 300 mg; Japanese Cohort 2; TAK-831 300 mg; Japanese Cohort 4; TAK-831 600 mg; Japanese Cohort 5; TAK-831

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead
• Takeda: collaborator

Study Sites (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Location

Results Point of Contact

• Title: Neurocrine Medical Information
• Organization: Neurocrine Biosciences

medinfo@neurocrine.com

877-641-3461

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: October 9, 2018
• Primary Completion: June 9, 2019
• Study Completion: June 19, 2019
• Last Updated: June 14, 2021
• Results First Posted: June 29, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)