Clincosm LogoSign in Get a demo

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

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT04163783
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
20
Actual Duration (Days)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 Following Single Oral Dose Administration in Healthy Male Subjects
Actual Study Start Date :
Mar 29, 2017
Actual Primary Completion Date :
Apr 18, 2017
Actual Study Completion Date :
Apr 18, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) [Up to 13 days]

  2. Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 [Up to 13 days]

  3. Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 [Up to 13 days]

  4. Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 [Up to 13 days]

  5. Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111 [Up to 13 days]

  6. Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111 [Up to 13 days]

  7. Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111 [Up to 13 days]

  8. Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 [Up to 13 days]

  9. Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 [Up to 13 days]

  10. Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) [Up to 13 days]

  11. Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 [Up to 13 days]

  12. Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111 [Up to 13 days]

  13. Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111 [Up to 13 days]

  14. 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]

  15. 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]

  16. 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]

  17. 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]

  18. 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]

  19. Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only) [Up to 13 days]

  20. 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]

  21. 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]

  22. Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef) [Up to 13 days]

  23. 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]

  24. Mass balance [Up to 13 days]

    Urine and fecal collection for Mass Balance Evaluation

  25. Routes of elimination of [14C]-BGB-3111 [Up to 13 days]

    Urine and fecal collection for Metabolite Profiling/Characterization

Secondary Outcome Measures

  1. Characterize and identify metabolites of [14C]-BGB-3111 [Up to 13 days]

    plasma, urine, and feces collection

  2. plasma and urine concentrations of BGB-3111 [up to 13 days]

    plasma and urine collection

  3. Number of Participants experiencing Adverse events (AEs) [up to 13 days]

  4. Number of Participants experiencing abnormal clinical laboratory evaluations [up to 13 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Clinical Research Unit, Inc., Madison Wisconsin United States 53704

Sponsors and Collaborators

  • BeiGene

Investigators

  • Study Director: William Novotony, MD, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT04163783
Other Study ID Numbers:
  • BGB-3111-105
First Posted:
Nov 15, 2019
Last Update Posted:
Nov 15, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BeiGene
Phase 1
Pharmacokinetics
Safety
Additional relevant MeSH terms:
Zanubrutinib

Study Results

No Results Posted as of Nov 15, 2019