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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-BGB-3111; Drug: 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).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit, Inc.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: William Novotony, MD, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): April 18, 2017
• Study Completion (Actual): April 18, 2017

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Phase 1
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Zanubrutinib
• Other Study ID Numbers: BGB-3111-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No