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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 Following Single Oral Dose Administration in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-BGB-3111
* Drug: BGB-3111


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Subjects will be administered a single oral dose of 320 mg of [14C]-BGB-3111 | Drug: [14C]-BGB-3111<br>* 20-mg capsule containing  200 μCi of [14C]-BGB-3111,<br>Drug: BGB-3111<br>* Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Time To Maximum Plasma Concentration (Tmax) 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: Half-life Period of (T1/2) 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: apparent volume of distribution during the terminal phase (Vz/F) 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 | Urine and fecal collection for Mass Balance Evaluation | Up to 13 days | 
| Routes of elimination of [14C]-BGB-3111 | Urine and fecal collection for Metabolite Profiling/Characterization | Up to 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize and identify metabolites of [14C]-BGB-3111 | plasma, urine, and feces collection | Up to 13 days | 
| plasma and urine concentrations of BGB-3111 | plasma and urine collection | up to 13 days | 
| Number of Participants experiencing Adverse events (AEs) |  | up to 13 days | 
| Number of Participants experiencing abnormal clinical laboratory evaluations |  | up to 13 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Pharmacokinetics, Safety