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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BGB-3111; Drug: [14C]-BGB-3111

Study type: Interventional

Funder types: Industry

Identifiers

NCT04163783

BGB-3111-105

Details and patient eligibility

About

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

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male between 18 and 65 years of age, inclusive, at Screening
2. Body mass index between 18.0 and 35.0 kg/m2, inclusive, at Screening
3. In good health, determined by no clinically significant findings from medical history,12-lead ECGs, or vital signs measurements
4. Clinical laboratory evaluations

Exclusion criteria

1. Significant history or clinical manifestation of any metabolic, allergic, infectious, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator [or designee]) prior to Check-in
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) prior to Check-in
3. History of stomach or intestinal surgery or resection that could alter absorption or excretion of orally administered drugs prior to Check-in except that appendectomy and hernia repair will be allowed if it was not associated with complications
4. Abnormal liver function tests

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Arm A

Experimental group

Description:

Subjects will be administered a single oral dose of 320 mg of \[14C\]-BGB-3111

Treatment:

Drug: BGB-3111

Drug: [14C]-BGB-3111