Trial | NCT00780182  Report issue

Title

Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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.
Study Started
Oct 31
2008
Primary Completion
Dec 31
2008
Study Completion
Jan 31
2009
Last Update
Feb 02
2010
Estimate

Drug CMX001

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

1 Experimental

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.

Criteria 

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
No Results Posted