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Single-dose Safety Study of APD916 in Healthy Volunteers

Primary Purpose

Narcolepsy With or Without Cataplexy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

APD916

About this trial

This is an interventional treatment trial for Narcolepsy With or Without Cataplexy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Community Research

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the pharmacokinetic properties of single, escalating doses of APD916

Pharmacokinetic samples (blood and urine) will be collected.

Full Information

NCT ID

NCT01093508

First Posted

March 24, 2010

Last Updated

November 1, 2010

Sponsor

Arena Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01093508

Brief Title

Single-dose Safety Study of APD916 in Healthy Volunteers

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 Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Arena Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Narcolepsy With or Without Cataplexy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

APD916

Primary Outcome Measure Information:

Title

To evaluate the safety and tolerability of single, escalating doses of APD916 when administered to healthy adult subjects

Description

Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters.

Time Frame

Single dose

Secondary Outcome Measure Information:

Title

To assess the pharmacokinetic properties of single, escalating doses of APD916

Description

Pharmacokinetic samples (blood and urine) will be collected.

Time Frame

Single dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Maynard, MD

Organizational Affiliation

Community Research, Cincinnati, OH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Community Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45255

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.arenapharm.com

Description

Related Info

Learn more about this trial

Single-dose Safety Study of APD916 in Healthy Volunteers

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