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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CMX001

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Rtp, North Carolina, United States, 27709
      • AAI Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC and Cmax of CMX001 and cidofovir	Each of 3 doses

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical and laboratory endpoints and adverse events	Throughout the study

Collaborators and Investigators

• Sponsor: Chimerix
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Evin H Sides, III, MD, AAIPharma

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: October 23, 2008
• First Submitted That Met QC Criteria: October 24, 2008
• First Posted (Estimate): October 27, 2008

Study Record Updates

• Last Update Posted (Estimate): February 2, 2010
• Last Update Submitted That Met QC Criteria: February 1, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Bioavailability
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Brincidofovir
• Other Study ID Numbers: CMX001-103; DMID-08-0020