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Single-Dose Safety Study of APD791 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00529646
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : December 30, 2008
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

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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

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

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

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United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Arena Pharmaceuticals
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Principal Investigator: Christen Anderson, MD, PhD Arena Pharmaceuticals
Additional Information:
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Responsible Party: Christen Anderson, MD, PhD, Arena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00529646    
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:
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Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs