Clinical trial NCT04163783: Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-BGB-3111 in Healthy Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Phase 1
Pharmacokinetics
Safety
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility 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

Primary outcomes:
measure: Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)
timeFrame: Up to 13 days
measure: Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Pharmacokinetic Parameter: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (λZ) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Blood and plasma concentrations of total radioactivity: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the amount excreted in urine per sampling interval (Aeu)
timeFrame: Up to 13 days
measure: Urinary recovery of total radioactivity of [14C]-BGB-3111 as assessed by the cumulative amount excreted in urine per sampling interval (Cum Aeu)
timeFrame: Up to 13 days
measure: 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)
timeFrame: Up to 13 days
measure: 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)
timeFrame: Up to 13 days
measure: Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only)
timeFrame: Up to 13 days
measure: Fecal recovery of total radioactivity as assessed by the amount of [14C]-BGB-3111 excreted in feces per sampling interval (Aef)
timeFrame: Up to 13 days
measure: Fecal recovery of total radioactivity as assessed by the cumulative amount of [14C]-BGB-3111 excreted in feces per sampling interval (Cum Aef)
timeFrame: Up to 13 days
measure: Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef)
timeFrame: Up to 13 days
measure: Fecal recovery of total radioactivity as assessed by the cumulative percentage of radioactive dose excreted in feces per sampling interval (Cum %Fef)
timeFrame: Up to 13 days
measure: Mass balance
timeFrame: Up to 13 days
measure: Routes of elimination of [14C]-BGB-3111
timeFrame: Up to 13 days
Secondary outcomes:
measure: Characterize and identify metabolites of [14C]-BGB-3111
timeFrame: Up to 13 days
measure: plasma and urine concentrations of BGB-3111
timeFrame: up to 13 days
measure: Number of Participants experiencing Adverse events (AEs)
timeFrame: up to 13 days
measure: Number of Participants experiencing abnormal clinical laboratory evaluations
timeFrame: up to 13 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.,
state: Wisconsin
Study officials:
affiliation: BeiGene
name: William Novotony, MD
role: STUDY_DIRECTOR
References: