NCT01093508

Single-dose Safety Study of APD916 in Healthy Volunteers

Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Arena Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Narcolepsy With or Without Cataplexy

Interventions

Type	Name	Description
DRUG	APD916

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-04-01
• Completion: 2010-07-01
• First posted: 2010-03-26
• Last updated: 2010-11-02

Locations

1 site across 1 country: United States