NCT00780182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 2, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

October 23, 2008

Last Update Submit

February 1, 2010

Conditions

Healthy

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (1)

  • AUC and Cmax of CMX001 and cidofovir

    Each of 3 doses

Secondary Outcomes (1)

  • Clinical and laboratory endpoints and adverse events

    Throughout the study

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

CMX001DRUG

CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and non-childbearing females 18-55 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AAI Pharma

Rtp, North Carolina, 27709, United States

Location

MeSH Terms

Interventions

brincidofovir

Study Officials

  • Evin H Sides, III, MD

    AAIPharma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 27, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

February 2, 2010

Record last verified: 2010-02

Locations

US(1)