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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163783
• Other study ID #: BGB-3111-105
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2017
• Est. completion date: April 18, 2017

Study information

• Verified date: November 2019
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 18, 2017
• Est. primary completion date: April 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-BGB-3111
20-mg capsule containing ~200 µCi of [14C]-BGB-3111,
• BGB-3111
Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.,	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Parameter: Plasma concentration of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)		Up to 13 days
Primary	Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111		Up to 13 days
Primary	Pharmacokinetic Parameter: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111		Up to 13 days
Primary	Pharmacokinetic Parameter: apparent terminal elimination rate constant (?Z) of [14C]-BGB-3111		Up to 13 days
Primary	Pharmacokinetic Parameter: Half-life Period of (T1/2) of [14C]-BGB-3111		Up to 13 days
Primary	Pharmacokinetic Parameter: apparent systemic clearance (CL/F) of [14C]-BGB-3111		Up to 13 days
Primary	Pharmacokinetic Parameter: apparent volume of distribution during the terminal phase (Vz/F) of [14C]-BGB-3111		Up to 13 days
Primary	Blood and plasma concentrations of total radioactivity: Maximum Plasma Concentration (Cmax) of [14C]-BGB-3111		Up to 13 days
Primary	Blood and plasma concentrations of total radioactivity: Time To Maximum Plasma Concentration (Tmax) of [14C]-BGB-3111		Up to 13 days
Primary	Blood and plasma concentrations of total radioactivity of [14C]-BGB-3111 as measured by area under concentration-time curve (AUC)		Up to 13 days
Primary	Blood and plasma concentrations of total radioactivity: apparent terminal elimination rate constant (?Z) of [14C]-BGB-3111		Up to 13 days
Primary	Blood and plasma concentrations of total radioactivity: Half-life Period of (T1/2) of [14C]-BGB-3111		Up to 13 days
Primary	Blood and plasma concentrations of total radioactivity: apparent systemic clearance (CL/F) of [14C]-BGB-3111		Up to 13 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Urinary recovery of total radioactivity as assessed by the renal clearance (CLR; for BGB-3111 only)		Up to 13 days
Primary	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
Primary	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
Primary	Fecal recovery of total radioactivity as assessed by the percentage of radioactive dose excreted in feces per sampling interval (%Fef)		Up to 13 days
Primary	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
Primary	Mass balance	Urine and fecal collection for Mass Balance Evaluation	Up to 13 days
Primary	Routes of elimination of [14C]-BGB-3111	Urine and fecal collection for Metabolite Profiling/Characterization	Up to 13 days
Secondary	Characterize and identify metabolites of [14C]-BGB-3111	plasma, urine, and feces collection	Up to 13 days
Secondary	plasma and urine concentrations of BGB-3111	plasma and urine collection	up to 13 days
Secondary	Number of Participants experiencing Adverse events (AEs)		up to 13 days
Secondary	Number of Participants experiencing abnormal clinical laboratory evaluations		up to 13 days