Single-dose Safety Study of APD916 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01093508|
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : November 2, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Narcolepsy With or Without Cataplexy||Drug: APD916||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||July 2010|
- To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects [ Time Frame: Single dose ]Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.
- To assess the pharmacokinetic properties of single, escalating doses of APD916 [ Time Frame: Single dose ]Pharmacokinetic samples (blood and urine) will be collected.
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093508
|United States, Ohio|
|Cincinnati, Ohio, United States, 45255|
|Principal Investigator:||James Maynard, MD||Community Research, Cincinnati, OH|
|Responsible Party:||Ronald Shazer, MD, Arena Pharmaceuticals, Inc.|
|Other Study ID Numbers:||
|First Posted:||March 26, 2010 Key Record Dates|
|Last Update Posted:||November 2, 2010|
|Last Verified:||November 2010|
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases