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

Launched by BEIGENE · Nov 12, 2019

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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