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 |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/27/2018 |
Start Date: | January 25, 2018 |
End Date: | April 16, 2018 |
A Two-Part Study Consisting of a Randomized, Placebo-Controlled, Single Dose Safety and Tolerability Study (Part A) Evaluating a Supratherapeutic Dose of Zanubrutinib Followed by a Randomized, Placebo- and Positive-Controlled, Crossover Study (Part B) to Evaluate the Effect of Zanubrutinib on Cardiac Repolarization in Healthy Volunteers
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
of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization in Healthy
Subjects
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 zanubrutinib in eight
(8) subjects.
Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover
study being conducted in about 28 subjects to investigate the effect of a single therapeutic
dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac
repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic
will be used as a positive control.
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 zanubrutinib in eight
(8) subjects.
Part B: This is a randomized, placebo and positive-controlled, double-blind, 4-way crossover
study being conducted in about 28 subjects to investigate the effect of a single therapeutic
dose of zanubrutinib, a supratherapeutic dose of zanubrutinib and placebo on cardiac
repolarization. Open-label Moxifloxacin (400 mg), a fluoroquinolone broad spectrum antibiotic
will be used as a positive control.
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.
We found this trial at
1
site
Secaucus, New Jersey 07094
Principal Investigator: Gregory Tracey, MD
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