NCT04454918

Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants

A Phase 1 Study to Assess Absolute Bioavailability of TAK-906 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine ABA of TAK-906 following single oral (capsule) administration of 50 milligram (mg) of TAK-906 and single intravenous (IV) microtracer dose administration of 100 microgram (μg) (approximately 1 microcurie \[μCi\]) of \[14C\]-TAK-906 in Period 1 (ABA), and to determine the mass balance of TAK-906 in urine and feces following a single oral (solution) administration of 50 mg (approximately 100 μCi) of \[14C\]-TAK-906 in Period 2 (absorption, distribution, metabolism, and elimination \[ADME\]).

Detailed description

The drug being tested in this study is called TAK-906. The study will determine ABA in Period 1, and ADME, and mass balance of TAK-906 after single oral administration in Period 2 in healthy adult male participants. Plasma and urine samples will be collected for PK determination; plasma, whole blood, urine, and feces samples will be collected for total radioactivity (TRA) determination; and plasma, urine, and feces samples will be collected to characterize the metabolite profiles of TAK-906. The study will enroll approximately 6 participants. The study is designed to consist of 2 periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1 (ABA study period), all participants will receive single unlabeled oral 50 mg dose of TAK-906 as capsule followed by microdose of 100 μg (approximately 1 μCi) \[14C\]-TAK-906 as intravenous infusion followed by a washout period of at least 7 days before the dose in Period 2. In Period 2 (ADME study period), all participants will receive a single dose of 50 mg (approximately 100 μCi) \[14C\]-TAK-906 as an oral solution. This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 65 days including screening period. Participants will be contacted approximately 30 days after the last dose of study drug for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-906 Oral Capsule	TAK-906 capsule.
DRUG	[14C]-TAK-906 Intravenous Infusion	\[14C\]-TAK-906 intravenous infusion.
DRUG	[14C]-TAK-906 Oral Solution	\[14C\]-TAK-906 oral solution.

Timeline

• Start date: 2020-07-30
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-07-02
• Last updated: 2022-03-07
• Results posted: 2022-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study