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

Completed · Phase 1

Conditions studied: Healthy Volunteers: Asian, Non-Asian

In brief

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

Key facts

Study ID

NCT03301181

Run by

BeiGene

People needed

40

Starts

2017-09-18

Expected to finish

2017-11-13

Last updated by the study team

2019-11-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index (BMI)18 - 32 kg/m2, inclusive.
• Subjects of Asian (first- or second-generation) and non-Asian descent.
• In good general health as assessed by the Investigator.
• Females must be nonpregnant and nonlactating, and females of childbearing potential will agree to use required contraception.
• Males without a vasectomy will agree to use required barrier contraception, and will agree to not donate sperm from the time of the first dose of BGB-3111 until ≥90 days after the last dose of BGB-3111.Able to comprehend and willing to sign consent.

You may not qualify if…

• Subjects with a clinically relevant history or presence of any clinically significant disease.
• Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the first dose of study drug.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
• History of alcoholism or drug/chemical abuse within prior year.

Where it is running

• West Coast Clinical Trials (WCCT) — Cypress, California, United States

Full record on ClinicalTrials.gov

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