A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers

This study has been completed.

First Received: February 11, 2008 Last Updated: December 29, 2008 History of Changes

Sponsored by:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00619931

Purpose

The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.

Condition	Intervention	Phase
Healthy	Drug: APD791	Phase I

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters [ Time Frame: Throughout study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic assessments [ Time Frame: Throughout study duration ] [ Designated as safety issue: No ]
Pharmacodynamic assessments (e.g., platelet function) [ Time Frame: Throughout study duration ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	January 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 APD791 or placebo	Drug: APD791 APD791 or matching placebo in escalating doses
2 APD791 or placebo	Drug: APD791 APD791 or matching placebo in escalating doses
3 APD791 or placebo	Drug: APD791 APD791 or matching placebo in escalating doses
4 APD791 or placebo	Drug: APD791 APD791 or matching placebo in escalating doses
5 APD791 or placebo	Drug: APD791 APD791 or matching placebo in escalating doses

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Healthy men and women

Criteria

Inclusion Criteria:

Healthy adult men and women, ages 19-45
Non smokers

Exclusion Criteria:

History of a bleeding disorder
Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
Recently donated blood or had significant blood loss
Current use of a prescription medication
Pregnant females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619931

Locations

United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Principal Investigator:	James Kisicki, MD	MDS Pharma Services
Study Director:	Christen M Anderson, MD, PhD	Arena Pharmaceuticals

More Information

Additional Information:

Arena Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Arena Pharmaceuticals ( c/o: Vice President and Chief Medical Officer )
Study ID Numbers:	APD791-002
Study First Received:	February 11, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00619931 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Arena Pharmaceuticals:

Healthy adult volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009