Single-dose Safety Study of APD916 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Narcolepsy With or Without Cataplexy

In brief

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

Key facts

Study ID

NCT01093508

Run by

Arena Pharmaceuticals

People needed

72

Starts

2010-03-01

Expected to finish

2010-07-01

Last updated by the study team

2010-11-02

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Community Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.