Single-dose Safety Study of APD916 in Healthy Volunteers

Narcolepsy With or Without Cataplexy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093508
• Other study ID #: APD916-001
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2010
• Last updated: November 1, 2010
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: Arena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Narcolepsy
• Narcolepsy With or Without Cataplexy

Intervention

Drug:
• APD916

Locations

Country	Name	City	State
United States	Community Research	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Arena Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Single dose	Yes
Secondary	To assess the pharmacokinetic properties of single, escalating doses of APD916	Pharmacokinetic samples (blood and urine) will be collected.	Single dose	Yes

External Links

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