A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects

• Status: Completed
• Trial end date: 2018-04-16
• Target enrollment: 0
• Participant gender: All

Summary

A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy Subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BeiGene
• Treatments: Moxifloxacin; Zanubrutinib

Criteria

Inclusion Criteria: All subjects

1. Body mass index (BMI) 18 - 33 kg/m2, inclusive.

2. In good general health as assessed by the Investigator.

3. Females of non-child bearing potential.

4. 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.

5. Able to comprehend and willing to sign consent.

Exclusion Criteria: All subjects

1. Subjects with a clinically relevant history or presence of any clinically significant disease.

2. Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease.

3. Women of child-bearing potential.

4. History of alcoholism or drug/chemical abuse within 6 months.