Covance Clinical Research Unit, Inc.,
Madison, Wisconsin, 53704, United States
NCT Number: NCT04163783
Phase 1 study in healthy subjects to determine the effect of an 8-hour fast from food on the pharmacokinetics of [14C]-BGB-3111.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Madison, Wisconsin, 53704, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20-mg capsule containing ~200 μCi of [14C]-BGB-3111,
Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Time frame: Up to 13 days
Urine and fecal collection for Mass Balance Evaluation
Time frame: Up to 13 days
Urine and fecal collection for Metabolite Profiling/Characterization
Time frame: Up to 13 days
plasma, urine, and feces collection
Time frame: up to 13 days
plasma and urine collection
Time frame: up to 13 days
Time frame: up to 13 days
BeiGene
Industry
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 Following Single Oral Dose Administration in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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