Healthy Volunteers
Conditions
Keywords
Phase 1, Pharmacokinetics, Safety
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).
Interventions
DRUG[14C]-BGB-3111
20-mg capsule containing \ 200 μCi of \[14C\]-BGB-3111,
DRUGBGB-3111
Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Routes of elimination of [14C]-BGB-3111 | Up to 13 days | Urine and fecal collection for Metabolite Profiling/Characterization |
| 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 | Up to 13 days | Urine and fecal collection for Mass Balance Evaluation |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma and urine concentrations of BGB-3111 | up to 13 days | plasma and urine collection |
| Number of Participants experiencing Adverse events (AEs) | up to 13 days | — |
| Number of Participants experiencing abnormal clinical laboratory evaluations | up to 13 days | — |
| Characterize and identify metabolites of [14C]-BGB-3111 | Up to 13 days | plasma, urine, and feces collection |
Countries
United States
Outcome results
None listed