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Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects

NCT03301181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-11-01

No results posted yet for this study

Summary

Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or itraconazole (Part B) on the pharmacokinetics of BGB-3111

Conditions

  • Healthy Volunteers: Asian, Non-Asian

Interventions

DRUG

BGB-3111 (Arm A)

320 mg BGB-3111 single oral dose

DRUG

Rifampin

600 mg rifampin once daily

DRUG

BGB-3111 (Arm B)

Up to 80 mg BGB-3111 single oral dose

DRUG

Itraconazole

200 mg itraconazole once daily

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • William Novotny, MD · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2017-11-07
Completion
2017-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301181 on ClinicalTrials.gov