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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 23, 2008

Last Updated Date

February 1, 2010

Start Date ^ICMJE

October 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

AUC and Cmax of CMX001 and cidofovir [ Time Frame: Each of 3 doses ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00780182 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical and laboratory endpoints and adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: CMX001

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

Study Arm (s)

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.

Intervention: Drug: CMX001

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00780182

Other Study ID Numbers ^ICMJE

CMX001-103, DMID-08-0020

Has Data Monitoring Committee

Yes

Responsible Party

Neil Frazer/ Chief Medical Officer, Chimerix

Study Sponsor ^ICMJE

Chimerix

Collaborators ^ICMJE

National Institutes of Health (NIH)

Investigators ^ICMJE

Principal Investigator:

Evin H Sides, III, MD

AAIPharma

Information Provided By

Chimerix

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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