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

NCT04163783 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-3111-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Phase 1; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (4)

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

  Up to 13 days

• plasma and urine concentrations of BGB-3111

  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

Study Arms (1)

Arm A

EXPERIMENTAL

Subjects will be administered a single oral dose of 320 mg of \[14C\]-BGB-3111

Drug: [14C]-BGB-3111; Drug: BGB-3111

Interventions

[14C]-BGB-3111 DRUG

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

Arm A

BGB-3111 DRUG

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

Arm A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.,

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

zanubrutinib

Study Officials

• William Novotony, MD

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 15, 2019
• Study Start: March 29, 2017
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)