Single-dose Safety Study of APD916 in Healthy Volunteers (NCT01093508) | Clinical Trial Compass
CompletedPhase 1
Single-dose Safety Study of APD916 in Healthy Volunteers
United States72 participantsStarted 2010-03
Plain-language summary
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
Who can participate
Age range18 Years – 45 Years
SexALL
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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
What they're measuring
1
To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects