CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
TAK-831 Oral Tablet +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04234672
NCT04234672Phase 1Completed
CompareCT.gov

A Phase 1 Study to Assess Absolute Bioavailability of TAK-831 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Subjects

Neurocrine Biosciences·interventional·Posted Jan 21, 2020·Updated Jun 30, 2021

In Brief

A Phase 1 clinical trial evaluating TAK-831 Oral Tablet, [14C]TAK-831 IV Infusion, and 1 other intervention for Healthy Volunteers. Completed, enrolled 6 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 21, 2020
Enrollment StartFeb 17, 2020
Primary CompletionApr 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.4 years ago

Interventions

TAK-831 Oral Tabletdrug

TAK-831 tablet.

[14C]TAK-831 IV Infusiondrug

\[14C\]TAK-831 IV infusion.

[14C]TAK-831 Oral Suspensiondrug

\[14C\]TAK-831 oral suspension.