Single-dose Safety Study of APD916 in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arena Pharmaceuticals

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