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
  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 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

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:
No publications provided

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

Keywords provided by Arena Pharmaceuticals:
Healthy adult volunteers

Additional relevant MeSH terms:
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014