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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT04163783

Run by

BeiGene

People needed

6

Starts

2017-03-29

Expected to finish

2017-04-18

Last updated by the study team

2019-11-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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
• 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
• 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
• Abnormal liver function tests

Where it is running

• Covance Clinical Research Unit, Inc., — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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