NCT04833049

Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults

A Phase 1 Study to Assess Absolute Bioavailability of TAK-994 and to Characterize Mass Balance, Pharmacokinetics, Absorption, Metabolism, and Excretion of [14C]TAK-994 in Male Healthy Subjects

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

Summary

The aim of this study is to understand how TAK-994 is processed by the body. This study will require participants to stay at the clinical research unit for 3 weeks to be monitored after receiving TAK-994.

Detailed description

The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy male participants. This study will characterize how TAK -994 is absorbed, metabolize, excreted by the body, after single oral administration by collecting plasma, urine, and feces samples for testing. The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and Part B. In Part A, all participants will receive TAK-994 as tablet and \[14C\]TAK-994 as intravenous infusion. In Part B, all participants will receive a single dose of \[14C\]TAK-994 as an oral suspension. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 67 days, including a 28-day screening period plus approximately 30 days for follow up.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-994 Oral Tablet	TAK-994 tablet.
DRUG	[14C]TAK-994 Intravenous Infusion	\[14C\]TAK-994 intravenous infusion.
DRUG	[14C]TAK-994 Oral Suspension	\[14C\]TAK-994 oral suspension.

Timeline

• Start date: 2021-04-14
• Primary completion: 2021-06-20
• Completion: 2021-06-20
• First posted: 2021-04-06
• Last updated: 2021-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study