Trial | NCT01093508  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    apd916 ...

  • Study Participants

    72
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose
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.
Study Started
Mar 31
2010
Primary Completion
Apr 30
2010
Study Completion
Jul 31
2010
Last Update
Nov 02
2010
Estimate

Drug APD916

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
No Results Posted