- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00529646
Single-Dose Safety Study of APD791 in Healthy Volunteers
December 29, 2008 updated by: Arena Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Lincoln, Nebraska, United States, 68502
- MDS Pharma Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
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Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetic and pharmacodynamic assessments
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christen Anderson, MD, PhD, Arena Pharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Study Registration Dates
First Submitted
September 12, 2007
First Submitted That Met QC Criteria
September 13, 2007
First Posted (Estimate)
September 14, 2007
Study Record Updates
Last Update Posted (Estimate)
December 30, 2008
Last Update Submitted That Met QC Criteria
December 29, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APD791-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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