NCT04649216

Excretion Balance, PK and Metabolism of a Single Oral Dose of [14C]PCO371

A Phase I, Single-Center, Open-Label Study Investigating the Excretion Balance, Pharmacokinetics (PK) and Metabolism of a Single Oral Dose of [14C]PCO371 and PK of an Intravenous (IV) Tracer of [14C]PCO371 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: Male
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I single center, open-label, non-randomized study in healthy male subjects, designed to evaluate the mass balance recovery, PK, metabolism and absolute bioavailability of single oral doses of PCO371. It is planned to enroll 12 subjects, with 6 subjects in each of 2 study parts. Subjects in Part 1 will receive a single oral dose of \[14C\]PCO371 Oral Solution. Subjects in Part 2 will receive a single oral dose of PCO371 capsules, followed by a single intravenous infusion of \[14C\]PCO371 Solution for Infusion over 10 min, starting 2 h post-oral dose. The study parts may be dosed in any order for logistical reasons (e.g. Part 2 may be dosed before Part 1). No subject will be permitted to take part in both study parts.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PCO371	PCO371 Capsule
DRUG	[14C]PCO371	\[14C\]PCO371 Oral solution
DRUG	[14C]PCO371	\[14C\]PCO371 Solution for infusion

Timeline

• Start date: 2020-11-25
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2020-12-02
• Last updated: 2021-03-01

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study