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

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00619931
First received: February 11, 2008
Last updated: December 29, 2008
Last verified: December 2008

February 11, 2008
December 29, 2008
January 2008
June 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00619931 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Healthy men and women

Healthy
Drug: APD791
APD791 or matching placebo in escalating doses
  • 1
    APD791 or placebo
    Intervention: Drug: APD791
  • 2
    APD791 or placebo
    Intervention: Drug: APD791
  • 3
    APD791 or placebo
    Intervention: Drug: APD791
  • 4
    APD791 or placebo
    Intervention: Drug: APD791
  • 5
    APD791 or placebo
    Intervention: Drug: APD791
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
19 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00619931
APD791-002
No
c/o: Vice President and Chief Medical Officer, Arena Pharmaceuticals
Arena Pharmaceuticals
Not Provided
Principal Investigator: James Kisicki, MD MDS Pharma Services
Study Director: Christen M Anderson, MD, PhD Arena Pharmaceuticals
Arena Pharmaceuticals
December 2008

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