Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
- Registration Number
- NCT04163783
- Lead Sponsor
- BeiGene
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A [14C]-BGB-3111 Subjects will be administered a single oral dose of 320 mg of \[14C\]-BGB-3111 Arm A BGB-3111 Subjects will be administered a single oral dose of 320 mg of \[14C\]-BGB-3111
- Primary Outcome Measures
Name Time Method Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111 Up to 13 days Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 Up to 13 days Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111 Up to 13 days Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) Up to 13 days Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 Up to 13 days Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111 Up to 13 days Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 Up to 13 days Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 Up to 13 days Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 Up to 13 days Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) Up to 13 days Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 Up to 13 days Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111 Up to 13 days Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111 Up to 13 days Blood and plasma concentrations of total radioactivity: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111 Up to 13 days Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the amount excreted in urine per sampling interval (Aeu) Up to 13 days Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative amount excreted in urine per sampling interval (Cum Aeu) Up to 13 days Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the percentage of drug or radioactive dose excreted in urine per sampling interval (%Feu) Up to 13 days Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative percentage of drug or radioactive dose excreted in urine (Cum %Feu) Up to 13 days Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only) Up to 13 days Fecal recovery of total radioactivity as assessed by the amount of [14C]-BGB-3111 excreted in feces per sampling interval (Aef) Up to 13 days Fecal recovery of total radioactivity as assessed by the cumulative amount of [14C]-BGB-3111 excreted in feces per sampling interval (Cum Aef) Up to 13 days Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef) Up to 13 days Fecal recovery of total radioactivity as assessed by the cumulative percentage of radioactive dose excreted in feces per sampling interval (Cum %Fef) Up to 13 days Mass balance Up to 13 days Urine and fecal collection for Mass Balance Evaluation
Routes of elimination of [14C]-BGB-3111 Up to 13 days Urine and fecal collection for Metabolite Profiling/Characterization
- Secondary Outcome Measures
Name Time Method Number of Participants experiencing Adverse events (AEs) up to 13 days Number of Participants experiencing abnormal clinical laboratory evaluations up to 13 days Characterize and identify metabolites of [14C]-BGB-3111 Up to 13 days plasma, urine, and feces collection
plasma and urine concentrations of BGB-3111 up to 13 days plasma and urine collection
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.,
🇺🇸Madison, Wisconsin, United States