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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-29

Study Completion Date

2017-04-18

Brief Summary

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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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Detailed Description

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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).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm A

Subjects will be administered a single oral dose of 320 mg of \[14C\]-BGB-3111

Group Type EXPERIMENTAL

[14C]-BGB-3111

Intervention Type DRUG

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

BGB-3111

Intervention Type DRUG

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

Interventions

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[14C]-BGB-3111

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

Intervention Type DRUG

BGB-3111

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes