Status:
COMPLETED
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
Lead Sponsor:
Jazz Pharmaceuticals
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy males and non-childbearing females 18-55 years old
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00780182
Start Date
October 1 2008
End Date
January 1 2009
Last Update
February 2 2010
Active Locations (1)
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1
AAI Pharma
Rtp, North Carolina, United States, 27709