Who is sponsoring NCT02566759?

NCT02566759 is sponsored by Neurocrine Biosciences.

What drugs are being tested in NCT02566759?

Interventions in NCT02566759: TAK-831 Oral Suspension, TAK-831 Placebo, TAK-831 Tablet.

What condition does NCT02566759 study?

NCT02566759 studies Schizophrenia, Cerebellar Ataxia.

Is NCT02566759 still recruiting?

NCT02566759 is currently terminated. Last updated 14 June 2021.

Are results published for NCT02566759?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-14 · How we verify

NCT02566759

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants

Terminated Phase 1 Results posted Last updated 14 June 2021

What this trial tests

Phase 1 trial testing TAK-831 Oral Suspension in Schizophrenia, Cerebellar Ataxia in 110 participants. Terminated before completion.

Timeline

23 September 2015

Primary endpoint
9 June 2016

12 July 2016

Quick facts

Lead sponsor	Neurocrine Biosciences
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	110
Start date	23 September 2015
Primary completion	9 June 2016
Estimated completion	12 July 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

TAK-831 Oral Suspension
TAK-831 Placebo
TAK-831 Tablet

Conditions studied

Schizophrenia, Cerebellar Ataxia — all drugs for Schizophrenia, Cerebellar Ataxia →

Sponsor

Neurocrine Biosciences — full company profile →

Who can join

Adults 18 to 55, any sex, with Schizophrenia, Cerebellar Ataxia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) Primary · 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)

Group	Value	95% CI
Part 1: Placebo Pooled	50.0
Part 1: TAK-831 10 mg	33.3
Part 1: TAK-831 30 mg	33.3
Part 1: TAK-831 100 mg	33.3
Part 1: TAK-831 250 mg	16.7
Part 1: TAK-831 500 mg	50.0
Part 1: TAK-831 750 mg	66.7
Part 2: Placebo Pooled	75.0
Part 2: TAK-831 30 mg	83.3
Part 2: TAK-831 100 mg	100.0
Part 2: TAK-831 200 mg	33.3
Part 2: TAK-831 400 mg	83.3

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose Primary · 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.

Group	Value	95% CI
Part 1: Placebo Pooled	0
Part 1: TAK-831 10 mg	0
Part 1: TAK-831 30 mg	0
Part 1: TAK-831 100 mg	0
Part 1: TAK-831 250 mg	0
Part 1: TAK-831 500 mg	0
Part 1: TAK-831 750 mg	16.7
Part 2: Placebo Pooled	0
Part 2: TAK-831 30 mg	0
Part 2: TAK-831 100 mg	33.3
Part 2: TAK-831 200 mg	0
Part 2: TAK-831 400 mg	0

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Primary · 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.

< lower criteria

Group	Value	95% CI
Part 1: Placebo Pooled	50.0
Part 1: TAK-831 10 mg	50.0
Part 1: TAK-831 30 mg	16.7
Part 1: TAK-831 100 mg	16.7
Part 1: TAK-831 250 mg	0
Part 1: TAK-831 500 mg	33.3
Part 1: TAK-831 750 mg	16.7
Part 2: Placebo Pooled	87.5
Part 2: TAK-831 30 mg	66.7
Part 2: TAK-831 100 mg	83.3
Part 2: TAK-831 200 mg	33.3
Part 2: TAK-831 400 mg	83.3

> greater criteria

Group	Value	95% CI
Part 1: Placebo Pooled	8.3
Part 1: TAK-831 10 mg	0
Part 1: TAK-831 30 mg	0
Part 1: TAK-831 100 mg	0
Part 1: TAK-831 250 mg	0
Part 1: TAK-831 500 mg	0
Part 1: TAK-831 750 mg	0
Part 2: Placebo Pooled	0
Part 2: TAK-831 30 mg	0
Part 2: TAK-831 100 mg	16.7
Part 2: TAK-831 200 mg	0
Part 2: TAK-831 400 mg	33.3

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose Primary · 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 ms

< lower cut-off point criteria

Group	Value	95% CI
Part 1: Placebo Pooled	41.7
Part 1: TAK-831 10 mg	33.3
Part 1: TAK-831 30 mg	16.7
Part 1: TAK-831 100 mg	50.0
Part 1: TAK-831 250 mg	16.7
Part 1: TAK-831 500 mg	33.3
Part 1: TAK-831 750 mg	16.7
Part 2: Placebo Pooled	37.5
Part 2: TAK-831 30 mg	33.3
Part 2: TAK-831 100 mg	50.0
Part 2: TAK-831 200 mg	0
Part 2: TAK-831 400 mg	16.7

> upper cut-off point criteria

Group	Value	95% CI
Part 1: Placebo Pooled	8.3
Part 1: TAK-831 10 mg	50.0
Part 1: TAK-831 30 mg	0
Part 1: TAK-831 100 mg	16.7
Part 1: TAK-831 250 mg	0
Part 1: TAK-831 500 mg	33.3
Part 1: TAK-831 750 mg	16.7
Part 2: Placebo Pooled	25.0
Part 2: TAK-831 30 mg	50.0
Part 2: TAK-831 100 mg	16.7
Part 2: TAK-831 200 mg	16.7
Part 2: TAK-831 400 mg	16.7

Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831 Secondary · 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

Group	Value	95% CI
Part 1: TAK-831 10 mg	90.7	± 26.95
Part 1: TAK-831 30 mg	313.3	± 121.97
Part 1: TAK-831 100 mg	567.7	± 218.76
Part 1: TAK-831 250 mg	905.8	± 329.53
Part 1: TAK-831 500 mg	1304.5	± 402.89
Part 1: TAK-831 750 mg	2121.7	± 554.92
Part 2: TAK-831 30 mg	167.1	± 39.95
Part 2: TAK-831 100 mg	467.2	± 84.36
Part 2: TAK-831 200 mg	1087.3	± 398.76
Part 2: TAK-831 400 mg	1095.5	± 236.86
Part 4: TAK-831 100 mg Tablet Fasted	216.0	± 104.68
Part 4: TAK-831 100 mg Tablet Fed	377.7	± 175.90

Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831 Secondary · Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose

Group	Value	95% CI
Part 2: TAK-831 30 mg	177.5	± 45.85
Part 2: TAK-831 100 mg	560.7	± 214.90
Part 2: TAK-831 200 mg	897.7	± 192.73
Part 2: TAK-831 400 mg	1269.5	± 451.37

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 Secondary · 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

Day 1

Group	Value	95% CI
Part 1: TAK-831 10 mg	0.250	0.23 – 0.50
Part 1: TAK-831 30 mg	0.260	0.25 – 0.33
Part 1: TAK-831 100 mg	0.435	0.23 – 1.50
Part 1: TAK-831 250 mg	0.275	0.23 – 2.02
Part 1: TAK-831 500 mg	0.725	0.20 – 1.00
Part 1: TAK-831 750 mg	0.760	0.25 – 2.02
Part 2: TAK-831 30 mg	0.500	0.47 – 0.68
Part 2: TAK-831 100 mg	0.500	0.17 – 2.00
Part 2: TAK-831 200 mg	0.375	0.17 – 1.02
Part 2: TAK-831 400 mg	0.500	0.15 – 1.00
Part 4: TAK-831 100 mg Tablet Fasted	0.930	0.25 – 4.00
Part 4: TAK-831 100 mg Tablet Fed	3.980	0.95 – 4.05

Day 16

Group	Value	95% CI
Part 1: TAK-831 10 mg	NA	NA – NA
Part 1: TAK-831 30 mg	NA	NA – NA
Part 1: TAK-831 100 mg	NA	NA – NA
Part 1: TAK-831 250 mg	NA	NA – NA
Part 1: TAK-831 500 mg	NA	NA – NA
Part 1: TAK-831 750 mg	NA	NA – NA
Part 2: TAK-831 30 mg	0.500	0.48 – 0.53
Part 2: TAK-831 100 mg	0.365	0.23 – 0.98
Part 2: TAK-831 200 mg	0.500	0.20 – 0.50
Part 2: TAK-831 400 mg	0.490	0.23 – 1.00
Part 4: TAK-831 100 mg Tablet Fasted	NA	NA – NA
Part 4: TAK-831 100 mg Tablet Fed	NA	NA – NA

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 Secondary · 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

Group	Value	95% CI
Part 1: TAK-831 10 mg	98.0	± 17.02
Part 1: TAK-831 30 mg	463.8	± 80.13
Part 1: TAK-831 100 mg	1186.8	± 256.67
Part 1: TAK-831 250 mg	1900.8	± 293.72
Part 1: TAK-831 500 mg	4111.1	± 1599.18
Part 1: TAK-831 750 mg	5374.0	± 1651.36
Part 2: TAK-831 30 mg	296.3	± 95.31
Part 2: TAK-831 100 mg	938.4	± 180.29
Part 2: TAK-831 200 mg	2030.2	± 265.73
Part 2: TAK-831 400 mg	2832.7	± 819.36
Part 4: TAK-831 100 mg Tablet Fasted	598.6	± 310.31
Part 4: TAK-831 100 mg Tablet Fed	1397.7	± 434.45

Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 Secondary · 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

Group	Value	95% CI
Part 1: TAK-831 10 mg	109.7	± 22.02
Part 1: TAK-831 30 mg	499.2	± 92.57
Part 1: TAK-831 100 mg	1271.4	± 253.26
Part 1: TAK-831 250 mg	1945.5	± 294.36
Part 1: TAK-831 500 mg	4140.7	± 1602.32
Part 1: TAK-831 750 mg	5512.0	± 1721.84
Part 2: TAK-831 30 mg	342.9	± 46.80
Part 2: TAK-831 100 mg	980.5	± 204.04
Part 2: TAK-831 200 mg	2092.7	± 273.06
Part 2: TAK-831 400 mg	2866.6	± 822.22
Part 4: TAK-831 100 mg Tablet Fasted	653.7	± 308.86
Part 4: TAK-831 100 mg Tablet Fed	1428.8	± 433.24

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 Secondary · Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose

Group	Value	95% CI
Part 2: TAK-831 30 mg	319.8	± 83.06
Part 2: TAK-831 100 mg	1211.0	± 236.45
Part 2: TAK-831 200 mg	1973.0	± 316.34
Part 2: TAK-831 400 mg	3452.6	± 1249.58

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 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). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Placebo Pooled

Serious: 0/12 (0%)

Deaths: —

Part 1: TAK-831 10 mg

Serious: 0/6 (0%)

Deaths: —

Part 1: TAK-831 30 mg

Serious: 0/6 (0%)

Deaths: —

Part 1: TAK-831 100 mg

Serious: 0/6 (0%)

Deaths: —

Part 1: TAK-831 250 mg

Serious: 0/6 (0%)

Deaths: —

Part 1: TAK-831 500 mg

Serious: 0/6 (0%)

Deaths: —

Part 1: TAK-831 750 mg

Serious: 0/6 (0%)

Deaths: —

Part 2: Placebo Pooled

Serious: 0/8 (0%)

Deaths: —

Part 2: TAK-831 30 mg

Serious: 0/6 (0%)

Deaths: —

Part 2: TAK-831 100 mg

Serious: 0/6 (0%)

Deaths: —

Part 2: TAK-831 200 mg

Serious: 0/6 (0%)

Deaths: —

Part 2: TAK-831 400 mg

Serious: 0/6 (0%)

Deaths: —

Part 3: Placebo

Serious: 0/1 (0%)

Deaths: —

Part 3: TAK-831 400 mg

Serious: 0/5 (0%)

Deaths: —

Part 4: TAK-831 100 mg Tablet Fasted

Serious: 0/23 (0%)

Deaths: —

Part 4: TAK-831 100 mg Tablet Fed

Serious: 0/23 (0%)

Deaths: —

Part 4: TAK-831 100 mg Suspension Fasted

Serious: 0/24 (0%)

Deaths: —

Other adverse events (57 terms — click to expand)

Reaction	System	Part 1: Placebo Pooled	Part 1: TAK-831 10 mg	Part 1: TAK-831 30 mg	Part 1: TAK-831 100 mg	Part 1: TAK-831 250 mg	Part 1: TAK-831 500 mg	Part 1: TAK-831 750 mg	Part 2: Placebo Pooled	Part 2: TAK-831 30 mg	Part 2: TAK-831 100 mg	Part 2: TAK-831 200 mg	Part 2: TAK-831 400 mg	Part 3: Placebo	Part 3: TAK-831 400 mg	Part 4: TAK-831 100 mg Tab…	Part 4: TAK-831 100 mg Tab…	Part 4: TAK-831 100 mg Sus…
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness postural	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle twitching	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Swollen tongue	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site bruise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site related reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling cold	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling abnormal	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fungal skin infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nail injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tremor	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Memory impairment	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Disorientation	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tearfulness	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02566759 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Results of a randomized double-blind study evaluating luvadaxistat in adults with Friedreich ataxia.
Wang H, Norton J, Xu L, DeMartinis N, et al · · 2021 · cited 10× · PMID 34018342 · DOI 10.1002/acn3.51373
Therapeutic potential of D-amino acid oxidase inhibitors for cognitive impairment associated with schizophrenia: learnings from luvadaxistat.
Terry-Lorenzo RT, Fan RH, Khin NA, Singh JB. · · 2024 · cited 5× · PMID 39756412 · DOI 10.1093/ijnp/pyae066

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02566759 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Neurocrine Biosciences
Last refreshed: 14 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02566759.

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NCT02566759

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other Neurocrine Biosciences trials

Verify against primary sources