Single-dose Safety Study of APD916 in Healthy Volunteers

Arena Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Narcolepsy With or Without Cataplexy

Treatments: Drug: APD916

Study type: Interventional

Funder types: Industry

Identifiers

NCT01093508

APD916-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy males or females ages 18-45 years
• Body weight of 50-100 kg (110-220 pounds)
• Eligible female subjects will be non-pregnant, evidenced by a negative serum pregnancy test at Screening and a urine dipstick pregnancy test on Day -1 (Check-In); non-lactating; surgically sterile, postmenopausal, or agree to continue to use a medically accepted method of birth control during and for at least 1 month after last study medication administration.
• Eligible male subjects will either be surgically sterile (i.e., vasectomy), for at least 3 months prior to screening, or agree to use a condom with spermicide when sexually active with a female partner who is not using an acceptable method of birth control during the study and for 1 month after.

Exclusion Criteria

• Subject who has donated any blood, or had significant blood loss within 56 days of dosing
• History of smoking or tobacco use within 3 months prior to dosing
• History of epilepsy or other seizure disorder
• Recent history (within 2 years prior to the screening visit) of sleep disorders
• History (within 2 years prior to the screening visit) of ADD or ADHD
• Traveled across more than 3 time zones within 2 weeks prior to dosing