ClinicalTrials.gov
ClinicalTrials.gov Menu

Single-Dose Safety Study of APD791 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00529646
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : December 30, 2008
Sponsor:
Information provided by:
Arena Pharmaceuticals

Brief Summary:
The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: APD791 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects
Study Start Date : July 2007



Primary Outcome Measures :
  1. Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters

Secondary Outcome Measures :
  1. Pharmacokinetic and pharmacodynamic assessments


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of a bleeding disorder
  • Recently donated blood or had significant blood loss
  • Current use of a prescription medication
  • Pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529646


Locations
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Principal Investigator: Christen Anderson, MD, PhD Arena Pharmaceuticals

Additional Information:
Responsible Party: Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00529646     History of Changes
Other Study ID Numbers: APD791-001
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: December 30, 2008
Last Verified: December 2008

Keywords provided by Arena Pharmaceuticals:
Healthy adult volunteers

Additional relevant MeSH terms:
APD791
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs