Healthy VolunteersPhase 1NCT03687684

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

A Phase 1 study testing TAK-831 in people with Healthy Volunteers, run by Neurocrine Biosciences at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TAK-831
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteJapan
Study dates: 9 Oct 2018to 19 Jun 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo

Other trials in Japan

About this study

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

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: Healthy Volunteers
Being tested: TAK-831, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-831Drug
TAK-831 Tablets.
PlaceboDrug
TAK-831 Matching Placebo Tablets.

Study groups in NCT03687684
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: TAK-831; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Oct 201819 Jun 2019

First posted27 Sep 2018
Study start9 Oct 2018
Primary completion9 Jun 2019
Study completion19 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03687684
Sponsor's protocol ID: TAK-831-1002
Other IDs: U1111-1219-2623, JapicCTI-184127
Status last verified: Jun 2021
First submitted: 26 Sep 2018
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03687684
Acronym / sponsor ID: TAK-831-1002
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Neurocrine BiosciencesIndustry (pharma, biotech, devices)
Collaborators: Takeda
Study start: 9 Oct 2018 (actual)
Primary completion: 9 Jun 2019 (actual)
Study completion: 19 Jun 2019 (actual)
First posted: 27 Sep 2018 (actual)
Results: Posted 29 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Japanese Cohort 1-A; TAK-831 100 mg + TAK-831 300 mg	Experimental	Drug: TAK-831TAK-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.
Japanese Cohort 1-B; TAK-831 100 mg + Placebo	Experimental	Drug: TAK-831, Drug: PlaceboTAK-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.
Japanese Cohort 1-C; Placebo + TAK-831 300 mg	Experimental	Drug: TAK-831, Drug: PlaceboTAK-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.
Japanese Cohort 2; TAK-831 300 mg	Experimental	Drug: TAK-831, Drug: PlaceboTAK-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.
Chinese Cohort 3; TAK-831 600 mg	Experimental	Drug: TAK-831, Drug: PlaceboTAK-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.
Japanese Cohort 4; TAK-831 600 mg	Experimental	Drug: TAK-831, Drug: PlaceboTAK-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.
Japanese Cohort 5; TAK-831	Experimental	Drug: TAK-831, Drug: PlaceboTAK-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.

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-831TAK-831 Tablets.	Drug	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
PlaceboTAK-831 Matching Placebo Tablets.	Drug	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

Primary outcome

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

6 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 and safety

Results posted to the registry on 29 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Japanese Cohort 1-A: TAK-831 100 mg + TAK-831 300 mg	4	4
Japanese Cohort 1-B: TAK-831 100 mg + Placebo	2	2
Japanese Cohort 1-C: Placebo + TAK-831 300 mg	2	2
Japanese Cohort 2, 4 and 5: Pooled Placebo	6	6
Japanese Cohort 2: TAK-831 300 mg	6	6
Japanese Cohort 4: TAK-831 600 mg	6	6
Japanese Cohort 5: TAK-831 50 mg	6	6
Chinese Cohort 3: Placebo	2	2
Chinese Cohort 3: TAK-831 600 mg	6	6

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Japanese Cohort 1: Placebo n = 4	Japanese Cohort 1: TAK-831 100 mg n = 6	Japanese Cohort 1: TAK-831 300 mg n = 6	Japanese Cohort 2, 4 and 5: Pooled Placebo n = 6	Japanese Cohort 2: TAK-831 300 mg n = 6	Japanese Cohort 4: TAK-831 600 mg n = 6	Japanese Cohort 5: TAK-831 50 mg n = 6	Chinese Cohort 3: Placebo n = 2	Chinese Cohort 3: TAK-831 600 mg n = 6
Value	0	2	0	4	4	1	2	1	2

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

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Japanese Cohort 1: Placebo n = 4	Japanese Cohort 1: TAK-831 100 mg n = 6	Japanese Cohort 1: TAK-831 300 mg n = 6	Japanese Cohort 2, 4 and 5: Pooled Placebo n = 6	Japanese Cohort 2: TAK-831 300 mg n = 6	Japanese Cohort 4: TAK-831 600 mg n = 6	Japanese Cohort 5: TAK-831 50 mg n = 6	Chinese Cohort 3: Placebo n = 6	Chinese Cohort 3: TAK-831 600 mg n = 2
Value	0	2	0	2	2	1	1	1	0

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

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Japanese Cohort 1: Placebo n = 4	Japanese Cohort 1: TAK-831 100 mg n = 6	Japanese Cohort 1: TAK-831 300 mg n = 6	Japanese Cohort 2, 4 and 5: Pooled Placebo n = 6	Japanese Cohort 2: TAK-831 300 mg n = 6	Japanese Cohort 4: TAK-831 600 mg n = 6	Japanese Cohort 5: TAK-831 50 mg n = 6	Chinese Cohort 3: Placebo n = 2	Chinese Cohort 3: TAK-831 600 mg n = 6
Value	0	0	0	1	1	0	0	0	0

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

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Japanese Cohort 1: Placebo n = 4	Japanese Cohort 1: TAK-831 100 mg n = 6	Japanese Cohort 1: TAK-831 300 mg n = 6	Japanese Cohort 2, 4 and 5: Pooled Placebo n = 6	Japanese Cohort 2: TAK-831 300 mg n = 6	Japanese Cohort 4: TAK-831 600 mg n = 6	Japanese Cohort 5: TAK-831 50 mg n = 6	Chinese Cohort 3: Placebo n = 2	Chinese Cohort 3: TAK-831 600 mg n = 6
Value	0	0	0	0	0	0	0	0	0

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

6 secondary outcomes are reported in the full results.

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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Japanese Cohort 1: Placebo	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Japanese Cohort 1: TAK-831 100 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Japanese Cohort 1: TAK-831 300 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Japanese Cohort 2, 4 and 5: Pooled Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Japanese Cohort 2: TAK-831 300 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Japanese Cohort 4: TAK-831 600 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Japanese Cohort 5: TAK-831 50 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Chinese Cohort 3: Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Chinese Cohort 3: TAK-831 600 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-831 in people with Healthy Volunteers, run by Neurocrine Biosciences at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.