Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CMX001

Intervention Type DRUG

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

Interventions

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CMX001

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes