drugset / Trial / NCT04234672

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

NCT04234672 ↗

Phase 1 Completed 6 enrolled Neurocrine Biosciences Takeda · collab
NaSingle-groupOpen-labelOther

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.

Timeline

Start
2020-02-17
Primary completion
2020-04-04
Completion
2020-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Luvadaxistat Small molecule 50 ug Intravenous
Subject Luvadaxistat Small molecule 500 mg Intravenous

Indications

No indication recorded.