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OpenTrials
Completed

NCT Number: NCT00780182

Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AAI Pharma

Rtp, North Carolina, 27709, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMX001

Drug

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

Primary outcomes

  1. AUC and Cmax of CMX001 and cidofovir

    Time frame: Each of 3 doses

Secondary outcomes

  1. Clinical and laboratory endpoints and adverse events

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

An Open-Label, Randomized, 3-Way Crossover, Single-Dose Study in Healthy Volunteers Comparing the Bioavailability of CMX001 (HDP-Cidofovir Conjugate) Delivered as a Tablet Formulation vs a Solution Formulation and the Effect of Food on CMX001 Bioavailability

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Oct 27, 2008
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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