A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Single Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Effect of Food on Pharmacokinetics of CAL-120 in Healthy Male Subjects
Completed
- Conditions
- cancersolid tumors10027656
- Registration Number
- NL-OMON35937
- Lead Sponsor
- Gilead Sciences (former Calistoga Pharmaceuticals, Inc.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Healthy male
Age between 18 and 65 years, inclusive.
BMI between 18 and 30 kg/m2, inclusive.
Non smoking or smoking a maximum of 5 cigarettes per day
Exclusion Criteria
Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of the study. In case of donating any blood or significant loss of blood within 60 days of the start of drug dosing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety, tolerability<br /><br>Pharmacokinetics</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacodynamics (by platelet aggregation and basophil activation , as well as<br /><br>the effect of food)</p><br>