Single-dose Safety Study of APD916 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01093508|
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : November 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy With or Without Cataplexy||Drug: APD916||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||July 2010|
- To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects [ Time Frame: Single dose ]Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.
- To assess the pharmacokinetic properties of single, escalating doses of APD916 [ Time Frame: Single dose ]Pharmacokinetic samples (blood and urine) will be collected.
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): NCT01093508
|United States, Ohio|
|Cincinnati, Ohio, United States, 45255|
|Principal Investigator:||James Maynard, MD||Community Research, Cincinnati, OH|