Schizophrenia, Cerebellar AtaxiaPhase 1NCT02566759
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
A Phase 1 study testing TAK-831 Oral Suspension and TAK-831 Tablet in people with Schizophrenia, Cerebellar Ataxia, run by Neurocrine Biosciences at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Cerebellar Ataxia
- What is being tested?
- TAK-831 Oral Suspension and TAK-831 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2015to 12 Jul 2016
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Should be capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Healthy male or female aged between 18 to 55 years- Weighing at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2).
- Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- Female participant with no childbearing potential, defined as a participant that has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who is post menopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone [FSH] greater than [>] 40 international units per liter [IU/L]).
Who cannot join
- Received any investigational compound within 3 months prior to randomization.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
- Has a known hypersensitivity to any component of the formulation of TAK-831.
- Female participant is of childbearing potential.
- Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in.
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- History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 single measure of spirits or 1 small glass of wine.
- Has taken any excluded medication, supplements, or food products during the time periods listed in the excluded medications and dietary products.
- Female participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
- Male participant intending to donate sperm during the course of this study or for 12 weeks after the last dose of study medication.
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash.
- Has a QT interval with Fridericia's correction method (QTcF) >450 millisecond (msec) (males) or >470 msec (females) or PR outside the range of 120 to 220 msec, confirmed with one repeat testing, at the screening visit or check-in (Day -2).
- Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention.
- Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
- Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen at Screening.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in. Cotinine test is positive at Screening or Check-in.
- Has poor peripheral venous access.
- Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of medication.
- Has a Screening or Check-in abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or designee.
- Has a supine blood pressure outside the ranges of 90 to 140 millimeter of mercury (mm Hg) for systolic and 50 to 90 mm Hg for diastolic, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
- Has a resting heart rate outside the range 40 to 100 bpm confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
- Has abnormal Screening or check-in laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) >1.5 the upper limits of normal.
- Has a risk of suicide according to the Investigator's clinical judgment (example, per The Columbia Suicide Severity Rating Scale [C-SSRS]), or has scored "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior", if this behaviour occurred in the past 2 years.
- Has received TAK-831 in a previous clinical study.
- Participant is vegan or vegetarian (Part 4 only - food effect).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-831 in Healthy Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
Read the detailed description
The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat participant who have schizophrenia and cerebellar ataxia. This study will look at the PK, safety and tolerability of TAK-831 in healthy participants. The study will enroll approximately 120 participants. The study will include 4 parts: Part 1 (single-rising dose [SRD]), Part 2 (SRD/multiple-rising dose [MRD]), Part 3 (MRD) and Part 4 (relative bioavailability study). Participants will be randomly assigned (by chance, like flipping a coin) to receive either active drug TAK-831 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Part 1, Cohort 1: single dose of TAK-831 100 mg
- Part 1, Cohort 2: single dose of TAK-831 250 mg
- Part 1, Cohort 3: single dose of TAK-831 500 mg
- Part 1, Cohort 4: single dose of TAK-831 30 mg
- Part 1, Cohort 5: single dose of TAK-831 750 mg
- Part 1, Cohort 6: single dose of TAK-831 10 mg
- Part 2, Cohort 1: single dose of TAK-831 30 mg
- Part 2, Cohort 2: single dose of TAK-831 100 mg
- Part 2, Cohort 3: single dose of TAK-831 200 mg
- Part 2, Cohort 4: single dose of TAK-831 400 mg
- Part 3, Cohort 1: TAK-831 400 mg
- Part 4: TAK-831 100 mg (Tablet Fasted + Tablet Fed + Suspension Fasted)
- Part 4: TAK-831 100 mg (Tablet Fed + Tablet Fasted + Suspension Fasted)
- Part 4: TAK-831 100 mg (Suspension Fasted+ Tablet Fed + Tablet Fasted)
Dosing with TAK-831 will progress into study Part 2, 3 and 4, only after review of all available safety, tolerability, and PK data collected in Cohorts 1 to 6 of the Study Part 1. This single center trial will be conducted in the United Kingdom. The overall time to participate in this study is approximately up to 58 days. Participants will be admitted in the clinic for the up to 20 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study, hence it is was not feasible to collect further CSF samples that were required to meet the exploratory objectives of the study. Part 1, 2 and 4 of the study were completed as planned.
- Conditions
- Schizophrenia, Cerebellar Ataxia
- Being tested
- TAK-831 Oral Suspension, TAK-831 Placebo, TAK-831 Tablet
- Keywords
- Drug therapy
- Medical subject headings
- Schizophrenia, Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-831 Oral SuspensionDrug
TAK-831 oral suspension.
TAK-831 PlaceboDrug
TAK-831 placebo-matching oral suspension.
TAK-831 TabletDrug
TAK-831 tablet.
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort 1: TAK-831 100 mg | Experimental | TAK-831 100 milligram (mg), suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 1, Cohort 2: TAK-831 250 mg | Experimental | TAK-831 250 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 1, Cohort 3: TAK-831 500 mg | Experimental | TAK-831 500 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 1, Cohort 4: TAK-831 30 mg | Experimental | TAK-831 30 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 1, Cohort 5: TAK-831 750 mg | Experimental | TAK-831 750 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 1, Cohort 6: TAK-831 10 mg | Experimental | TAK-831 10 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 2, Cohort 1: TAK-831 30 mg | Experimental | TAK-831 30 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 2, Cohort 2: TAK-831 100 mg | Experimental | TAK-831 100 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 2, Cohort 3: TAK-831 200 mg | Experimental | TAK-831 200 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 2, Cohort 4: TAK-831 400 mg | Experimental | TAK-831 400 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 3, Cohort 1: TAK-831 400 mg | Experimental | TAK-831 400 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once daily from Days 1 to 14. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Placebo |
| Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted) | Experimental | TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Tablet |
| Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted) | Experimental | TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Tablet |
| Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted) | Experimental | TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3. Receives: Drug: TAK-831 Oral Suspension; Drug: TAK-831 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Clinical laboratory tests included hematology, serum chemistry and urinalysis.
Measured: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Markedly abnormal criteria for vital signs measurement was assessed. The lower criteria and upper criteria for abnormality are as follow: systolic blood pressure at less than (<) 85 millimeter of mercury (mm Hg) to greater than (>) 180 mm Hg; diastolic blood pressure < 50 mm Hg to >110 mm Hg; pulse rate <50 bpm to >120 bpm; Temperature <35.6 degree Celsius to >37.7 degree Celsius.
Measured: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Markedly abnormal criteria for ECG was assessed. The lower cut-off point criteria and upper cut-off point criteria are as follow: heart rate <50 beats per minute (bpm) to >120 bpm; PR interval less than or equal to (<=) 80 millisecond (msec) to greater than or equal to (>=) 200 msec; QRS interval <=80 msec to >=180 msec; QT interval <=300 msec to >=460 msec; QTcB interval <=300 msec to >=500 msec or >=30 msec change from baseline and >=450 msec; QT interval with Fridericia's correction method (QTcF) interval <=50 msec to >=500 msec or >=30 msec change from baseline and >=450 msec.
Measured: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Secondary outcomes (6)
Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831
Measured: Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose; Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Part 1, 2 and 4: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Measured: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 2 and 3: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-831
Measured: Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 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.
- First posted2 Oct 2015 (estimated)
- Study start23 Sep 2015
- Primary completion9 Jun 2016
- Study completion12 Jul 2016
Why it stopped: The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study.
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 Schizophrenia, Cerebellar AtaxiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566759
- Sponsor's protocol ID
- TAK-831-1001
- Other IDs
- 2015-002295-24, U1111-1168-6568, 15/SC/0412, 2015
- Status last verified
- Jun 2021
- First submitted
- 1 Oct 2015
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of TAK-831 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02566759
- Acronym / sponsor ID
- TAK-831-1001
- Conditions
- Schizophrenia, Cerebellar Ataxia
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- 23 Sep 2015
- Primary completion
- 9 Jun 2016 (actual)
- Study completion
- 12 Jul 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Posted 6 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
Detailed description
The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat participant who have schizophrenia and cerebellar ataxia. This study will look at the PK, safety and tolerability of TAK-831 in healthy participants. The study will enroll approximately 120 participants. The study will include 4 parts: Part 1 (single-rising dose [SRD]), Part 2 (SRD/multiple-rising dose [MRD]), Part 3 (MRD) and Part 4 (relative bioavailability study). Participants will be randomly assigned (by chance, like flipping a coin) to receive either active drug TAK-831 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Part 1, Cohort 1: single dose of TAK-831 100 mg
- Part 1, Cohort 2: single dose of TAK-831 250 mg
- Part 1, Cohort 3: single dose of TAK-831 500 mg
- Part 1, Cohort 4: single dose of TAK-831 30 mg
- Part 1, Cohort 5: single dose of TAK-831 750 mg
- Part 1, Cohort 6: single dose of TAK-831 10 mg
- Part 2, Cohort 1: single dose of TAK-831 30 mg
- Part 2, Cohort 2: single dose of TAK-831 100 mg
- Part 2, Cohort 3: single dose of TAK-831 200 mg
- Part 2, Cohort 4: single dose of TAK-831 400 mg
- Part 3, Cohort 1: TAK-831 400 mg
- Part 4: TAK-831 100 mg (Tablet Fasted + Tablet Fed + Suspension Fasted)
- Part 4: TAK-831 100 mg (Tablet Fed + Tablet Fasted + Suspension Fasted)
- Part 4: TAK-831 100 mg (Suspension Fasted+ Tablet Fed + Tablet Fasted)
Dosing with TAK-831 will progress into study Part 2, 3 and 4, only after review of all available safety, tolerability, and PK data collected in Cohorts 1 to 6 of the Study Part 1. This single center trial will be conducted in the United Kingdom. The overall time to participate in this study is approximately up to 58 days. Participants will be admitted in the clinic for the up to 20 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study, hence it is was not feasible to collect further CSF samples that were required to meet the exploratory objectives of the study. Part 1, 2 and 4 of the study were completed as planned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1, Cohort 1: TAK-831 100 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 100 milligram (mg), suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. |
| Part 1, Cohort 2: TAK-831 250 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 250 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. |
| Part 1, Cohort 3: TAK-831 500 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 500 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. |
| Part 1, Cohort 4: TAK-831 30 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 30 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. |
| Part 1, Cohort 5: TAK-831 750 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 750 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. |
| Part 1, Cohort 6: TAK-831 10 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 10 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1. |
| Part 2, Cohort 1: TAK-831 30 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 30 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. |
| Part 2, Cohort 2: TAK-831 100 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 100 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. |
| Part 2, Cohort 3: TAK-831 200 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 200 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. |
| Part 2, Cohort 4: TAK-831 400 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 400 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once on Day 1 and once daily from Days 4 to 16. |
| Part 3, Cohort 1: TAK-831 400 mg | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 PlaceboTAK-831 400 mg, suspension, orally or TAK-831 placebo-matching suspension, orally, once daily from Days 1 to 14. |
| Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted) | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 TabletTAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3. |
| Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted) | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 TabletTAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3. |
| Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted) | Experimental | Drug: TAK-831 Oral Suspension, Drug: TAK-831 TabletTAK-831 100 mg, suspension, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 1, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once 30 minutes after starting a high fat meal on Day 1 of Period 2, followed by a washout interval of 5 days, further followed by TAK-831 100 mg, tablet, orally, once after an overnight fast of at least 10 hours on Day 1 of Period 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Should be capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Healthy male or female aged between 18 to 55 years- Weighing at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2).
- Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- Female participant with no childbearing potential, defined as a participant that has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who is post menopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone [FSH] greater than [>] 40 international units per liter [IU/L]).
Key exclusion criteria (25 listed)
- Received any investigational compound within 3 months prior to randomization.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
- Has a known hypersensitivity to any component of the formulation of TAK-831.
- Female participant is of childbearing potential.
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-831 Oral SuspensionTAK-831 oral suspension. | Drug | Part 1, Cohort 1: TAK-831 100 mg, Part 1, Cohort 2: TAK-831 250 mg, Part 1, Cohort 3: TAK-831 500 mg, Part 1, Cohort 4: TAK-831 30 mg, Part 1, Cohort 5: TAK-831 750 mg, Part 1, Cohort 6: TAK-831 10 mg, Part 2, Cohort 1: TAK-831 30 mg, Part 2, Cohort 2: TAK-831 100 mg, Part 2, Cohort 3: TAK-831 200 mg, Part 2, Cohort 4: TAK-831 400 mg, Part 3, Cohort 1: TAK-831 400 mg, Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted), Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted), Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted) |
| TAK-831 PlaceboTAK-831 placebo-matching oral suspension. | Drug | Part 1, Cohort 1: TAK-831 100 mg, Part 1, Cohort 2: TAK-831 250 mg, Part 1, Cohort 3: TAK-831 500 mg, Part 1, Cohort 4: TAK-831 30 mg, Part 1, Cohort 5: TAK-831 750 mg, Part 1, Cohort 6: TAK-831 10 mg, Part 2, Cohort 1: TAK-831 30 mg, Part 2, Cohort 2: TAK-831 100 mg, Part 2, Cohort 3: TAK-831 200 mg, Part 2, Cohort 4: TAK-831 400 mg, Part 3, Cohort 1: TAK-831 400 mg |
| TAK-831 TabletTAK-831 tablet. | Drug | Part 4:TAK-831(Suspension Fasted+ Tablet Fed + Tablet Fasted), Part 4:TAK-831(Tablet Fasted+ Tablet Fed + Suspension Fasted), Part 4:TAK-831(Tablet Fed + Tablet Fasted + Suspension Fasted) |
Primary outcome
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Clinical laboratory tests included hematology, serum chemistry and urinalysis.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Markedly abnormal criteria for vital signs measurement was assessed. The lower criteria and upper criteria for abnormality are as follow: systolic blood pressure at less than (<) 85 millimeter of mercury (mm Hg) to greater than (>) 180 mm Hg; diastolic blood pressure < 50 mm Hg to >110 mm Hg; pulse rate <50 bpm to >120 bpm; Temperature <35.6 degree Celsius to >37.7 degree Celsius.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
Markedly abnormal criteria for ECG was assessed. The lower cut-off point criteria and upper cut-off point criteria are as follow: heart rate <50 beats per minute (bpm) to >120 bpm; PR interval less than or equal to (<=) 80 millisecond (msec) to greater than or equal to (>=) 200 msec; QRS interval <=80 msec to >=180 msec; QT interval <=300 msec to >=460 msec; QTcB interval <=300 msec to >=500 msec or >=30 msec change from baseline and >=450 msec; QT interval with Fridericia's correction method (QTcF) interval <=50 msec to >=500 msec or >=30 msec change from baseline and >=450 msec.
6 secondary outcomes
Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831
Time frame: Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose; Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Part 1, 2 and 4: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose
Part 2 and 3: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-831
Time frame: Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose
Results and safety
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
Related trials for Schizophrenia, Cerebellar Ataxia
RecruitingObservational study
Neuroimmunology Registry and Biobank
Encephalopathy, Psychosis
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 Oral Suspension and TAK-831 Tablet in people with Schizophrenia, Cerebellar Ataxia, run by Neurocrine Biosciences at 1 site in United Kingdom.
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 5 inclusion and 25 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: stopped early, 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 United Kingdom. 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 6 Feb 2018). 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?
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) (time frame: Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.