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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
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Clinical and laboratory endpoints and adverse events [ Time Frame: Throughout the study ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Chimerix:
Bioavailability

ClinicalTrials.gov processed this record on September 21, 2017