NCT02716987 is a Phase 1 clinical trial of TAK-831 in Healthy, sponsored by Neurocrine Biosciences.

Who is sponsoring NCT02716987?

NCT02716987 is sponsored by Neurocrine Biosciences.

What drugs are being tested in NCT02716987?

Interventions in NCT02716987: TAK-831, [18F]PGM299.

Is NCT02716987 still recruiting?

NCT02716987 is currently completed. Last updated 14 June 2021.

Are results published for NCT02716987?

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

NCT02716987

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

Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration

Completed Phase 1 Results posted Last updated 14 June 2021

What this trial tests

Phase 1 trial testing TAK-831 in Healthy in 20 participants. Completed in 30 August 2016.

Timeline

21 March 2016

Primary endpoint
30 August 2016

30 August 2016

Quick facts

Lead sponsor	Neurocrine Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	20
Start date	21 March 2016
Primary completion	30 August 2016
Estimated completion	30 August 2016
Sites	1 location across United Kingdom

Drugs / interventions tested

TAK-831 — full drug profile →
[18F]PGM299 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Neurocrine Biosciences — full company profile →

Who can join

Adults 25 to 55, male only, with Healthy. 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.

Total Volume of Distribution (VT) of [18F]PGM299 in the Cerebellar Grey Matter (GM) for Each PET Scan Primary · Set A: Baseline (PET scan 1), 2 hours (PET scan 2) and 26 hours (PET scan 3) post-TAK-831 dose; Set B: Day 1 (PET scan 1) and Day 10 (PET scan 2)

Participant 1- PET Scan 1

Group	Value	95% CI
Set A: TAK-831 100 mg	1.211
Set A: TAK-831 200 mg	1.247
Set A: TAK-831 250 mg	1.349
Set A: TAK-831 500 mg	1.683
Set B: [18F]PGM299	0.658
Set A: [18F]PGM299 Baseline	0.863

Participant 1- PET Scan 2

Group	Value	95% CI
Set A: TAK-831 100 mg	0.400
Set A: TAK-831 200 mg	0.126
Set A: TAK-831 250 mg	0.247
Set A: TAK-831 500 mg	0.114
Set B: [18F]PGM299	1.109
Set A: [18F]PGM299 Baseline	NA

Participant 1- PET Scan 3

Group	Value	95% CI
Set A: TAK-831 100 mg	1.467
Set A: TAK-831 200 mg	0.543
Set A: TAK-831 250 mg	0.58
Set A: TAK-831 500 mg	1.182
Set B: [18F]PGM299	NA
Set A: [18F]PGM299 Baseline	NA

Participant 2- PET Scan 1

Group	Value	95% CI
Set A: TAK-831 100 mg	0.663
Set A: TAK-831 200 mg	1.585
Set A: TAK-831 250 mg	0.743
Set A: TAK-831 500 mg	2.095
Set B: [18F]PGM299	0.884
Set A: [18F]PGM299 Baseline	NA

Participant 2- PET Scan 2

Group	Value	95% CI
Set A: TAK-831 100 mg	0.241
Set A: TAK-831 200 mg	0.217
Set A: TAK-831 250 mg	0.266
Set A: TAK-831 500 mg	0.172
Set B: [18F]PGM299	1.130
Set A: [18F]PGM299 Baseline	NA

Participant 2- PET Scan 3

Group	Value	95% CI
Set A: TAK-831 100 mg	0.809
Set A: TAK-831 200 mg	0.77
Set A: TAK-831 250 mg	0.425
Set A: TAK-831 500 mg	0.553
Set B: [18F]PGM299	NA
Set A: [18F]PGM299 Baseline	NA

Participant 3- PET Scan 1

Group	Value	95% CI
Set A: TAK-831 100 mg	1.397
Set A: TAK-831 200 mg	NA
Set A: TAK-831 250 mg	0.981
Set A: TAK-831 500 mg	NA
Set B: [18F]PGM299	1.504
Set A: [18F]PGM299 Baseline	NA

Participant 3- PET Scan 2

Group	Value	95% CI
Set A: TAK-831 100 mg	0.858
Set A: TAK-831 200 mg	NA
Set A: TAK-831 250 mg	0.189
Set A: TAK-831 500 mg	NA
Set B: [18F]PGM299	1.388
Set A: [18F]PGM299 Baseline	NA

Non-displaceable Binding Potential (BPND) of [18F]PGM299 in the Cerebellar GM for Each PET Scan Primary · Set A: Baseline (PET scan 1), 2 hours (PET scan 2) and 26 hours (PET scan 3) post-TAK-831 dose; Set B: Day 1 (PET scan 1) and Day 10 (PET scan 2)

Participant 1- PET Scan 1

Group	Value	95% CI
Set A: TAK-831 100 mg	10.99
Set A: TAK-831 200 mg	7.31
Set A: TAK-831 250 mg	6.71
Set A: TAK-831 500 mg	8.96
Set B: [18F]PGM299	3.77
Set A: [18F]PGM299 Baseline	5.49

Participant 1- PET Scan 2

Group	Value	95% CI
Set A: TAK-831 100 mg	3.26
Set A: TAK-831 200 mg	-0.28
Set A: TAK-831 250 mg	0.47
Set A: TAK-831 500 mg	-0.20
Set B: [18F]PGM299	4.99
Set A: [18F]PGM299 Baseline	NA

Participant 1- PET Scan 3

Group	Value	95% CI
Set A: TAK-831 100 mg	7.89
Set A: TAK-831 200 mg	4.22
Set A: TAK-831 250 mg	4.32
Set A: TAK-831 500 mg	11.19
Set B: [18F]PGM299	NA
Set A: [18F]PGM299 Baseline	NA

Participant 2- PET Scan 1

Group	Value	95% CI
Set A: TAK-831 100 mg	3.88
Set A: TAK-831 200 mg	8.38
Set A: TAK-831 250 mg	3.53
Set A: TAK-831 500 mg	13.35
Set B: [18F]PGM299	13.49
Set A: [18F]PGM299 Baseline	NA

Participant 2- PET Scan 2

Group	Value	95% CI
Set A: TAK-831 100 mg	1.01
Set A: TAK-831 200 mg	0.16
Set A: TAK-831 250 mg	0.25
Set A: TAK-831 500 mg	0.06
Set B: [18F]PGM299	5.89
Set A: [18F]PGM299 Baseline	NA

Participant 2- PET Scan 3

Group	Value	95% CI
Set A: TAK-831 100 mg	4.39
Set A: TAK-831 200 mg	6.06
Set A: TAK-831 250 mg	2.17
Set A: TAK-831 500 mg	4.59
Set B: [18F]PGM299	NA
Set A: [18F]PGM299 Baseline	NA

Participant 3- PET Scan 1

Group	Value	95% CI
Set A: TAK-831 100 mg	7.22
Set A: TAK-831 200 mg	NA
Set A: TAK-831 250 mg	4.80
Set A: TAK-831 500 mg	NA
Set B: [18F]PGM299	7.13
Set A: [18F]PGM299 Baseline	NA

Participant 3- PET Scan 2

Group	Value	95% CI
Set A: TAK-831 100 mg	5.13
Set A: TAK-831 200 mg	NA
Set A: TAK-831 250 mg	0.01
Set A: TAK-831 500 mg	NA
Set B: [18F]PGM299	7.46
Set A: [18F]PGM299 Baseline	NA

Set A: EC50- Plasma Concentration of TAK-831 That Corresponds to 50 Percent (%) DAO Brain Enzyme Occupancy in Cerebellum Secondary · Set A: Baseline, 2 and 26 hours post-TAK-831 dose

EC50 was obtained from global VT model. The affinity constant relating plasma concentration of TAK-831 to DAO occupancy (EC50) was estimated by fitting the PET and plasma concentration data (VT, Cp). It was calculated as VT= VsBase (EC50/EC50+Cp) + VND, where Vs Base was the group-level (global) volume of distribution of the specific binding in the target region (cerebellar GM) and VND was the volume of distribution of the non-displaceable component (non-specific bound and free radiotracer) of the target region.

Group	Value	95% CI
Set A: All Participants	12.7	2.3 – 23.1

Set A: Dose of TAK-831 That Corresponds to 50% DAO Brain Enzyme Occupancy in Cerebellum Secondary · Set A: At 2 and 26 hours post-TAK-831 dose

Dose of TAK-831 that corresponds to 50% DAO brain enzyme occupancy in cerebellum at the time of maximum observed plasma concentration (Tmax) of TAK-831 was estimated.

Group	Value	95% CI
Set A: All Participants	100

Set B: Coefficient of Variation (CoV) of [18F]PGM299 Binding in Healthy Human Brain Secondary · Set B: Baseline up to Day 10

CoV was calculated as COV (P)(%) = 100 \* mean/ standard deviation, where P was different participant scanned under baseline condition.

Group	Value	95% CI
Set B: [18F]PGM299	30.13

Set A: Plasma Concentrations of TAK-831 During Each Post-TAK-831 Dosing PET Scan Periods Secondary · Set A: Days 1 and 2 At time 0 (at tracer injection), 60 minutes after tracer injection and 120 minutes after tracer injection for each post TAK-831 dosing PET scan period

Day 1: pre-tracer dose

Group	Value	95% CI
Set A: TAK-831 100 mg	211.250	163.00 – 271.00
Set A: TAK-831 200 mg	416.500	201.00 – 632.00
Set A: TAK-831 250 mg	273.750	168.00 – 321.00
Set A: TAK-831 500 mg	1404.500	889.00 – 1920.00

Day 1: 60 minutes post-tracer dose

Group	Value	95% CI
Set A: TAK-831 100 mg	83.375	55.40 – 95.80
Set A: TAK-831 200 mg	129.050	78.10 – 180.00
Set A: TAK-831 250 mg	122.725	68.90 – 196.00
Set A: TAK-831 500 mg	376.500	254.00 – 499.00

Day 1: 120 minutes post-tracer dose

Group	Value	95% CI
Set A: TAK-831 100 mg	42.500	24.70 – 48.70
Set A: TAK-831 200 mg	82.000	64.00 – 100.00
Set A: TAK-831 250 mg	89.925	46.00 – 176.00
Set A: TAK-831 500 mg	176.000	130.00 – 222.00

Day 2: pre-tracer dose

Group	Value	95% CI
Set A: TAK-831 100 mg	4.028	2.74 – 7.21
Set A: TAK-831 200 mg	7.360	5.89 – 8.83
Set A: TAK-831 250 mg	11.025	8.17 – 14.20
Set A: TAK-831 500 mg	23.400	12.70 – 34.10

Day 2: 60 minutes post-tracer dose

Group	Value	95% CI
Set A: TAK-831 100 mg	3.140	1.62 – 5.74
Set A: TAK-831 200 mg	5.205	4.41 – 6.00
Set A: TAK-831 250 mg	9.658	6.60 – 13.80
Set A: TAK-831 500 mg	28.455	9.61 – 47.30

Day 2: 120 minutes post-tracer dose

Group	Value	95% CI
Set A: TAK-831 100 mg	3.123	1.26 – 5.89
Set A: TAK-831 200 mg	5.380	3.82 – 6.94
Set A: TAK-831 250 mg	8.665	5.70 – 14.60
Set A: TAK-831 500 mg	33.975	8.15 – 59.80

Set A: Percent Change From Baseline to Post-TAK-831 Dose in AUEC(0-24)Serine: Area Under the Effect-time Curve From Time 0 to 24 Hours Post-TAK-831 Dose for Dextro-serine (D-serine) and Levo-serine (L-serine) Secondary · Set A: Baseline, 24 hours post-TAK-831 dose

D-serine

Group	Value	95% CI
Set A: TAK-831 100 mg	8.65	± 7.209
Set A: TAK-831 200 mg	21.90	± NA
Set A: TAK-831 250 mg	18.08	± 8.309
Set A: TAK-831 500 mg	8.70	± NA

L-serine

Group	Value	95% CI
Set A: TAK-831 100 mg	10.88	± 5.905
Set A: TAK-831 200 mg	2.00	± NA
Set A: TAK-831 250 mg	-2.46	± 10.301
Set A: TAK-831 500 mg	5.10	± NA

Set A: Percent Change From Baseline to Post-TAK-831 Dose in AUEC(0-24)Serine: Area Under the Effect-time Curve From Time 0 to 24 Hours Post-TAK-831 Dose for Ratio of D-serine to Total Serine Secondary · Set A: Baseline, 24 hours post-TAK-831 dose

Group	Value	95% CI
Set A: TAK-831 100 mg	-1.18	± 4.748
Set A: TAK-831 200 mg	19.75	± NA
Set A: TAK-831 250 mg	21.30	± 6.958
Set A: TAK-831 500 mg	6.25	± NA

Set A: Percent Change in Maximum Drug-induced Effect (Emax,Serine) on Change in Plasma Concentrations of D-serine and L-serine Secondary · Set A: Baseline, 24 hours post-TAK-831 dose

D-serine

Group	Value	95% CI
Set A: TAK-831 100 mg	9.58	± 9.769
Set A: TAK-831 200 mg	27.05	± NA
Set A: TAK-831 250 mg	17.46	± 9.122
Set A: TAK-831 500 mg	40.30	± NA

L-serine

Group	Value	95% CI
Set A: TAK-831 100 mg	17.40	± 7.318
Set A: TAK-831 200 mg	11.50	± NA
Set A: TAK-831 250 mg	-2.02	± 12.917
Set A: TAK-831 500 mg	16.10	± NA

Set A: Percent Change in Maximum Drug-induced Effect (Emax, D: Total Serine Ratio) on the Ratio of D-serine to Total Serine Secondary · Set A: Baseline, 24 hours post-TAK-831 dose

Group	Value	95% CI
Set A: TAK-831 100 mg	-1.40	± 9.515
Set A: TAK-831 200 mg	20.95	± NA
Set A: TAK-831 250 mg	25.38	± 12.604
Set A: TAK-831 500 mg	20.45	± NA

Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for D-serine and L-serine Secondary · Set A: Day -1 At 1, 4 and 12 hours post check-in and Day 1 pre-dose and at multiple time points (up to 24 hours) post-TAK-831 dose

D-serine: Day -1

Group	Value	95% CI
Set A: TAK-831 100 mg	4.955	1.00 – 12.00
Set A: TAK-831 200 mg	1.000	1.00 – 1.00
Set A: TAK-831 250 mg	3.320	1.00 – 10.60
Set A: TAK-831 500 mg	11.900	11.90 – NA

D-serine: Day 1

Group	Value	95% CI
Set A: TAK-831 100 mg	18.000	12.00 – 20.00
Set A: TAK-831 200 mg	18.000	12.00 – 24.00
Set A: TAK-831 250 mg	15.206	4.03 – 20.00
Set A: TAK-831 500 mg	25.100	20.00 – 30.20

L-serine: Day -1

Group	Value	95% CI
Set A: TAK-831 100 mg	4.267	1.00 – 10.80
Set A: TAK-831 200 mg	5.750	1.00 – 10.50
Set A: TAK-831 250 mg	6.086	2.33 – 10.60
Set A: TAK-831 500 mg	2.350	2.35 – NA

L-serine: Day 1

Group	Value	95% CI
Set A: TAK-831 100 mg	13.993	3.97 – 20.00
Set A: TAK-831 200 mg	24.000	24.00 – 24.00
Set A: TAK-831 250 mg	12.026	4.03 – 20.00
Set A: TAK-831 500 mg	30.200	30.20 – NA

Set A: Time to Reach the Maximum PD Effect (Time to Emax,Serine) for Ratio of D-serine to Total Serine Secondary · Set A: Day -1 At 1, 4 and 12 hours post check-in and Day 1 pre-dose and at multiple time points (up to 24 hours) post-TAK-831 dose

Day -1

Group	Value	95% CI
Set A: TAK-831 100 mg	6.875	1.00 – 12.00
Set A: TAK-831 200 mg	1.000	1.00 – NA
Set A: TAK-831 250 mg	1.875	1.00 – 2.50
Set A: TAK-831 500 mg	11.100	10.30 – 11.90

Day 1

Group	Value	95% CI
Set A: TAK-831 100 mg	26.725	23.60 – 29.90
Set A: TAK-831 200 mg	25.000	20.00 – 30.00
Set A: TAK-831 250 mg	23.750	8.05 – 30.40
Set A: TAK-831 500 mg	30.100	30.00 – 30.20

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 15 in set A and up to Day 12 in set B.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Set A: [18F]PGM299 Dose 1 to Prior TAK-831 100 mg Dose

Serious: 0/4 (0%)

Deaths: —

Set A: [18F]PGM299 Dose 1 to Prior TAK-831 200 mg Dose

Serious: 0/2 (0%)

Deaths: —

Set A: [18F]PGM299 Dose 1 to Prior TAK-831 250 mg Dose

Serious: 0/5 (0%)

Deaths: —

Set A: [18F]PGM299 Dose 1 to Prior TAK-831 500 mg Dose

Serious: 0/2 (0%)

Deaths: —

Set A: TAK-831 100 mg Dose to Prior [18F]PGM299 Dose 2

Serious: 0/4 (0%)

Deaths: —

Set A: TAK-831 200 mg Dose to Prior [18F]PGM299 Dose 2

Serious: 0/2 (0%)

Deaths: —

Set A: TAK-831 250 mg Dose to Prior [18F]PGM299 Dose 2

Serious: 0/5 (0%)

Deaths: —

Set A: TAK-831 500 mg Dose to Prior [18F]PGM299 Dose 2

Serious: 0/2 (0%)

Deaths: —

SetA:TAK-831 100mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)

Serious: 0/4 (0%)

Deaths: —

SetA:TAK-831 200mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)

Serious: 0/2 (0%)

Deaths: —

SetA:TAK-831 250mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)

Serious: 0/5 (0%)

Deaths: —

SetA:TAK-831 500mg:[18F]PGM299 Dose 3 up to Follow-up (Day 15)

Serious: 0/2 (0%)

Deaths: —

Set B: [18F]PGM299

Serious: 0/6 (0%)

Deaths: —

Set A: [18F]PGM299 Baseline

Serious: 0/1 (0%)

Deaths: —

Other adverse events (9 terms — click to expand)

Reaction	System	Set A: [18F]PGM299 Dose 1 …	Set A: [18F]PGM299 Dose 1 …	Set A: [18F]PGM299 Dose 1 …	Set A: [18F]PGM299 Dose 1 …	Set A: TAK-831 100 mg Dose…	Set A: TAK-831 200 mg Dose…	Set A: TAK-831 250 mg Dose…	Set A: TAK-831 500 mg Dose…	SetA:TAK-831 100mg:[18F]PG…	SetA:TAK-831 200mg:[18F]PG…	SetA:TAK-831 250mg:[18F]PG…	SetA:TAK-831 500mg:[18F]PG…	Set B: [18F]PGM299	Set A: [18F]PGM299 Baseline
Catheter site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Throat irritation	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site bruise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Catheter site haematoma	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral coldness	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02716987 adverse events section.

Sponsor's own description

The purpose of this study is to determine the relationship between TAK-831 dose, plasma exposure, extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following single oral dosing of TAK-831 in healthy participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

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 NCT02716987 (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/NCT02716987.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02716987

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 trials of TAK-831

Other recruiting trials for Healthy

Other Neurocrine Biosciences trials

Verify against primary sources