Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
NCT02268760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103
Last updated 2014-10-20
Summary
To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW
1. In rising single doses
2. With and without a 64 g fat breakfast at one selected dose
Conditions
- Healthy
Interventions
- DRUG
-
BILN 2061 ZW single rising doses
- DRUG
- DRUG
-
BILN 2061 ZW fixed dose
- OTHER
-
Standardized breakfast
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2001-06-30
- Primary Completion
- 2001-09-30
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