Single-dose Safety Study of APD916 in Healthy Volunteers
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects [ Time Frame: Single dose ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Pharmacokinetic samples (blood and urine) will be collected.
|Study Start Date:||March 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive APD916). Each cohort will be assigned to receive a single dose of APD916. After dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (PI) and Sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.
|United States, Ohio|
|Cincinnati, Ohio, United States, 45255|
|Principal Investigator:||James Maynard, MD||Community Research, Cincinnati, OH|