Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00780182

Run by

Jazz Pharmaceuticals

People needed

24

Starts

2008-10-01

Expected to finish

2009-01-01

Last updated by the study team

2010-02-02

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and non-childbearing females 18-55 years old

You may not qualify if…

• 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

Where it is running

• AAI Pharma — Rtp, North Carolina, United States

Full record on ClinicalTrials.gov

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