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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163783
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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
Healthy Volunteers Drug: [14C]-BGB-3111 Drug: BGB-3111 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
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Study Type : Interventional  (Clinical Trial)
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 : March 29, 2017
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : April 18, 2017
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC) [ Time Frame: Up to 13 days ]
  2. Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  3. Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  4. Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  5. Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  6. Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  7. Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  8. Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  9. Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111 [ Time Frame: 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) [ Time Frame: Up to 13 days ]
  11. Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  12. Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
  13. Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 13 days ]
  19. Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 13 days ]
  24. Mass balance [ Time Frame: Up to 13 days ]
    Urine and fecal collection for Mass Balance Evaluation

  25. Routes of elimination of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
    Urine and fecal collection for Metabolite Profiling/Characterization


Secondary Outcome Measures :
  1. Characterize and identify metabolites of [14C]-BGB-3111 [ Time Frame: Up to 13 days ]
    plasma, urine, and feces collection

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

  3. Number of Participants experiencing Adverse events (AEs) [ Time Frame: up to 13 days ]
  4. Number of Participants experiencing abnormal clinical laboratory evaluations [ Time Frame: up to 13 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163783


Locations
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United States, Wisconsin
Covance Clinical Research Unit, Inc.,
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: William Novotony, MD BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04163783    
Other Study ID Numbers: BGB-3111-105
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action