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Completed

NCT Number: NCT04163783

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.,

Madison, Wisconsin, 53704, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

[14C]-BGB-3111

Drug

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

BGB-3111

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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