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Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Chimerix
ClinicalTrials.gov Identifier:
NCT00780182
First received: October 23, 2008
Last updated: February 1, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: CMX001
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by Chimerix:

Primary Outcome Measures:
  • AUC and Cmax of CMX001 and cidofovir [ Time Frame: Each of 3 doses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical and laboratory endpoints and adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
 Drug: CMX001
CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780182

Locations
United States, North Carolina
AAI Pharma
Rtp, North Carolina, United States, 27709
Sponsors and Collaborators
Chimerix
National Institutes of Health (NIH)
Investigators
Principal Investigator: Evin H Sides, III, MD AAIPharma
  More Information

No publications provided

Responsible Party: Neil Frazer/ Chief Medical Officer, Chimerix
ClinicalTrials.gov Identifier: NCT00780182     History of Changes
Other Study ID Numbers: CMX001-103, DMID-08-0020
Study First Received: October 23, 2008
Last Updated: February 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Chimerix:
Bioavailability

ClinicalTrials.gov processed this record on May 16, 2013