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Single-dose Safety Study of APD916 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01093508
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : November 2, 2010
Information provided by:
Arena Pharmaceuticals

Brief Summary:
The APD916-001 study is designed primarily to evaluate the safety and tolerability of APD916 when administered as a single dose

Condition or disease Intervention/treatment Phase
Narcolepsy With or Without Cataplexy Drug: APD916 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. To assess the pharmacokinetic properties of single, escalating doses of APD916 [ Time Frame: Single dose ]
    Pharmacokinetic samples (blood and urine) will be collected.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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

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United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45255
Sponsors and Collaborators
Arena Pharmaceuticals
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Principal Investigator: James Maynard, MD Community Research, Cincinnati, OH
Additional Information:
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Responsible Party: Ronald Shazer, MD, Arena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01093508    
Other Study ID Numbers: APD916-001
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders