Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
- Registration Number
- NCT00780182
- Lead Sponsor
- Chimerix
- Brief Summary
The purpose of this study is to compare the bioavailability of CMX001 when administered as a tablet vs a solution and to determine the effect of a high-fat meal on CMX001 bioavailability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Healthy males and non-childbearing females 18-55 years old
Exclusion Criteria
- Use of an investigational drug and/or treatment within 30 days prior to enrollment.
- Positive HIV, Hepatitis B or Hepatitis C test result
- Tobacco user
- History of GI disease or disorder
- History of positive fecal occult blood test (FOBT)
- Body Mass Index (BMI) > 30 or < 18, or body weight < 50 kg
- Prior abdominal or pelvic surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 CMX001 All subjects will receive three 40mg doses of CMX001 as 1)solution fasted, 2)tablet fasted and 3)tablet following a high-fat breakfast. The order in which each subject receives each of the doses will be determined by a randomization code.
- Primary Outcome Measures
Name Time Method AUC and Cmax of CMX001 and cidofovir Each of 3 doses
- Secondary Outcome Measures
Name Time Method Clinical and laboratory endpoints and adverse events Throughout the study
Trial Locations
- Locations (1)
AAI Pharma
🇺🇸Rtp, North Carolina, United States