Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CMX001

• Registration Number: NCT00780182
• Lead Sponsor: Chimerix

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	CMX001	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.

Primary Outcome Measures

Name	Time	Method
AUC and Cmax of CMX001 and cidofovir	Each of 3 doses

Secondary Outcome Measures

Name	Time	Method
Clinical and laboratory endpoints and adverse events	Throughout the study

Trial Locations

Locations (1)

AAI Pharma; 🇺🇸 Rtp, North Carolina, United States