NCT04234672 is a Phase 1 clinical trial of TAK-831 Oral Tablet in Healthy Volunteers, sponsored by Neurocrine Biosciences.

Who is sponsoring NCT04234672?

NCT04234672 is sponsored by Neurocrine Biosciences.

What drugs are being tested in NCT04234672?

Interventions in NCT04234672: TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, [14C]TAK-831 Oral Suspension.

What condition does NCT04234672 study?

NCT04234672 studies Healthy Volunteers.

Is NCT04234672 still recruiting?

NCT04234672 is currently completed. Last updated 30 June 2021.

Are results published for NCT04234672?

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

Last reviewed 2021-06-30 · How we verify

NCT04234672

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

A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

Completed Phase 1 Results posted Last updated 30 June 2021

What this trial tests

Phase 1 trial testing TAK-831 Oral Tablet in Healthy Volunteers in 6 participants. Completed in 4 April 2020.

Timeline

17 February 2020

Primary endpoint
4 April 2020

4 April 2020

Quick facts

Lead sponsor	Neurocrine Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	6
Start date	17 February 2020
Primary completion	4 April 2020
Estimated completion	4 April 2020
Sites	1 location across United States

Drugs / interventions tested

TAK-831 Oral Tablet
[14C]TAK-831 IV Infusion — full drug profile →
[14C]TAK-831 Oral Suspension — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Neurocrine Biosciences — full company profile →

Who can join

Adults 19 to 55, male only, with Healthy Volunteers. 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.

Period 1: Percent Absolute Bioavailability (%F) for TAK-831 Primary · Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as \[Actual Dose (IV) x AUCinf (oral)\] / \[Actual Dose (oral) x AUCinf (IV)\] x 100.

Group	Value	95% CI
TAK-831 500 mg + [14C]TAK-831 50 μg	17.34	± 31.3

Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose] Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	88.66	± 3.6

Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe) Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	472.7	± 3.3

Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR]) Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	27.50	± 19.8

Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe]) Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	60.71	± 5.9

Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831 Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Group	Value	95% CI
[14C]TAK-831 500 mg	1243	± 33.2

Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831 Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	0.799	0.52 – 1.05

Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	10.314	± 6.3900

Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831 Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	4198	± 30.8

Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831 Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	4171	± 30.8

Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	5878	± 11.4

Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) Primary · Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Group	Value	95% CI
[14C]TAK-831 500 mg	2.005	1.01 – 4.17

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TAK-831 500 mg

Serious: 0/6 (0%)

Deaths: 0/6

[14C]TAK-831 50 μg

Serious: 0/6 (0%)

Deaths: 0/6

[14C]TAK-831 500 mg

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (3 terms — click to expand)

Reaction	System	TAK-831 500 mg	[14C]TAK-831 50 μg	[14C]TAK-831 500 mg
Eye irritation	Eye disorders	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT04234672 adverse events section.

Sponsor's own description

The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) \[14C\]TAK-831 in Period 2.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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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 NCT04234672 (US National Library of Medicine, public domain)
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: 30 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/NCT04234672.

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

NCT04234672

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 recruiting trials for Healthy Volunteers

Other Neurocrine Biosciences trials

Verify against primary sources