Clinical Trial: Single-dose Safety Study of APD916 in Healthy Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose

Detailed Summary: 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.
Sponsor: Arena Pharmaceuticals

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: To assess the pharmacokinetic properties of single, escalating doses of APD916 [ Time Frame: Single dose ]

Pharmacokinetic samples (blood and urine) will be collected.


Original Secondary Outcome: Same as current

Information By: Arena Pharmaceuticals

Dates:
Date Received: March 24, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 1, 2010
Last Verified: November 2010