Narcolepsy With or Without Cataplexy
Conditions
Brief 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.
Interventions
DRUGAPD916
Sponsors
Arena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects | Single dose | Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the pharmacokinetic properties of single, escalating doses of APD916 | Single dose | Pharmacokinetic samples (blood and urine) will be collected. |
Countries
United States
Outcome results
None listed