Comparative Bioavailability and Effect of Food on CMX001... | NCT00780182

Studies
Comparative Bioavailability and Effect of Food on CMX001 in Healthy Volunteers

NCT00780182

Sponsor

Jazz Pharmaceuticals

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

24Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

CMX001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DMID-08-0020

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Oct 23, 2008

First Submission Date that Met QC Criteria

Oct 24, 2008

First Posted Date

Oct 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CMX001	Drug	CMX001 tablet fasted, CMX001 tablet fed, CMX001 solution fasted	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC and Cmax of CMX001 and cidofovir		Each of 3 doses

Secondary Outcomes

Measure	Description	Time Frame
Clinical and laboratory endpoints and adverse events		Throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evin H Sides, III, MD	AAIPharma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AAI Pharma		Rtp	North Carolina	27709	United States

Intervention Browse Module

MeSH Terms

ID	Term
C525733	brincidofovir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided