Status:
COMPLETED
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
Lead Sponsor:
BeiGene
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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
Detailed Description
This is a Two-Part Phase 1 Study. Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of z...
Eligibility Criteria
Inclusion
- All subjects
- Body mass index (BMI) 18 - 33 kg/m2, inclusive.
- In good general health as assessed by the Investigator.
- Females of non-child bearing potential.
- 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.
Exclusion
- All subjects
- Subjects with a clinically relevant history or presence of any clinically significant disease.
- Personal or known family history of congenital or acquired long QT syndrome or cardiovascular disease.
- Women of child-bearing potential.
- History of alcoholism or drug/chemical abuse within 6 months.
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03432884
Start Date
January 25 2018
End Date
April 16 2018
Last Update
April 24 2020
Active Locations (1)
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1
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07094