NCT03408470

TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of \[14C\]-TD-1473. Subjects in cohort 2 will receive a single oral dose of \[14C\]-TD-1473 only.

Conditions

• Intestinal Disorders
• Bowel Diseases, Inflammatory

Interventions

Type	Name	Description
DRUG	TD-1473 oral capsule	(Intervention description included in arm description)
DRUG	[14C]-TD-1473 IV bolus	(Intervention description included in arm description)
DRUG	[14C]-TD-1473 Oral Capsule	(Intervention description included in arm description)

Timeline

• Start date: 2018-01-31
• Primary completion: 2018-02-21
• Completion: 2018-02-21
• First posted: 2018-01-24
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study