Single-dose Safety Study of APD916 in Healthy Volunteers

Study Overview
=================
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.

Official Title
-----------------
Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability and Pharmacokinetics of APD916 Administered to Healthy Adult Subjects

Conditions
-----------------
Narcolepsy With or Without Cataplexy

Intervention / Treatment
-----------------
* Drug: APD916


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: APD916|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects | Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters. | Single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetic properties of single, escalating doses of APD916 | Pharmacokinetic samples (blood and urine) will be collected. | Single dose |