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COMPLETED
NCT04992442
PHASE1

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: A Phase 1 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 Adult Male Participants

Key Details

Gender

MALE

Age Range

19 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2020-07-09

Completion Date

2020-08-18

Last Updated

2026-09-14

Healthy Volunteers

Yes

Interventions

DRUG

TAK-935 Oral Tablet

TAK-935 tablet

DRUG

[14C]TAK-935 IV Infusion

\[14C\]TAK-935 IV infusion

DRUG

[14C]TAK-935 Oral Solution

\[14C\]TAK-935 oral solution

Locations (1)

Celerion

Lincoln, Nebraska, United States