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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00780182

Enrollment

Registered

2008-10-27

Start date

2008-10-31

Completion date

2009-01-31

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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.

Interventions

DRUGCMX001

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC and Cmax of CMX001 and cidofovir	Each of 3 doses

Secondary

Measure	Time frame
Clinical and laboratory endpoints and adverse events	Throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026