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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014