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

BeiGene6 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

[14C]-BGB-3111DRUG

20-mg capsule containing \~200 μCi of \[14C\]-BGB-3111,

BGB-3111DRUG

Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Clinical Research Unit, Inc.,

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)

Time frame: Up to 13 days

Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111

Time frame: Up to 13 days

Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111

Time frame: Up to 13 days

Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111

Time frame: Up to 13 days

Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111

Time frame: Up to 13 days

Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111

Time frame: Up to 13 days

Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111

Time frame: Up to 13 days

Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111

Time frame: Up to 13 days

Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111

Time frame: Up to 13 days

Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)

Time frame: Up to 13 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111

Time frame: Up to 13 days

Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111

Time frame: Up to 13 days

Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Up to 13 days

Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only)

Time frame: 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)

Time frame: 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)

Time frame: Up to 13 days

Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef)

Time frame: 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)

Time frame: Up to 13 days

Mass balance

Urine and fecal collection for Mass Balance Evaluation

Time frame: Up to 13 days

Routes of elimination of [14C]-BGB-3111

Urine and fecal collection for Metabolite Profiling/Characterization

Time frame: Up to 13 days

Secondary Outcomes

Characterize and identify metabolites of [14C]-BGB-3111

plasma, urine, and feces collection

Time frame: Up to 13 days

plasma and urine concentrations of BGB-3111

plasma and urine collection

Time frame: up to 13 days

Number of Participants experiencing Adverse events (AEs)

Time frame: up to 13 days

Number of Participants experiencing abnormal clinical laboratory evaluations

Time frame: up to 13 days