Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Chimerix

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CMX001

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00780182

DMID-08-0020

CMX001-103

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: CMX001