NCT04163783

Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 Following Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of \[14C\]-BGB-3111.

Detailed description

This study will be an open-label, non-randomized study to evaluate the pharmacokinetics of \[14C\]-BGB-3111 when administered in healthy male subjects following at least an 8-hour fast from food (not including water).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[14C]-BGB-3111	20-mg capsule containing \~200 μCi of \[14C\]-BGB-3111,
DRUG	BGB-3111	Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111

Timeline

• Start date: 2017-03-29
• Primary completion: 2017-04-18
• Completion: 2017-04-18
• First posted: 2019-11-15
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study