Single-Dose Safety Study of APD791 in Healthy Volunteers
Sponsor
Arena Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00529646
Collaborator
(none)
90
1
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Jul 1, 2007
Outcome Measures
Primary Outcome Measures
- Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters []
Secondary Outcome Measures
- Pharmacokinetic and pharmacodynamic assessments []
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 45 Years
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MDS Pharma Services | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Arena Pharmaceuticals
Investigators
- Principal Investigator: Christen Anderson, MD, PhD, Arena Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00529646
Other Study ID Numbers:
- APD791-001
First Posted:
Sep 14, 2007
Last Update Posted:
Dec 30, 2008
Last Verified:
Dec 1, 2008