Trial record 3 of 3 for:    NARCOLEPSY 1

Single-dose Safety Study of APD916 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01093508
First received: March 24, 2010
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects [ Time Frame: Single dose ] [ Designated as safety issue: Yes ]
    Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.


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


Estimated Enrollment: 72
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093508

Locations
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45255
Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
Principal Investigator: James Maynard, MD Community Research, Cincinnati, OH
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald Shazer, MD, Arena Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01093508     History of Changes
Other Study ID Numbers: APD916-001
Study First Received: March 24, 2010
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Narcolepsy
Cataplexy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014