drugset / Trial / NCT04992442

Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants

NCT04992442

Phase 1 Completed 6 enrolled Takeda
NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-935 and a single oral administration of 3×100 mg milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance, characterize the pharmacokinetics (PK) of TAK-935 and metabolite \[M-I (N-oxide)\] in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 300 mg (approximately 100 μCi) \[14C\]TAK-935 in Treatment Period 2.

Timeline

Start
2020-07-09
Primary completion
2020-08-18
Completion
2020-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Soticlestat Small molecule 50 ug Intravenous
Subject Soticlestat Small molecule 300 mg Intravenous

Indications

No indication recorded.