A Study Of The Effect Of PF-04802540 On Sleep Measures

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04802540; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772512

B0911003

Details and patient eligibility

About

The purpose of this study is to determine if PF-04802540 decreases REM sleep.

Enrollment: 13 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive
• Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight >45 kg (99 lbs)
• Non-users of nicotine

Exclusion criteria

• Evidence or history of clinically significant medical illness
• A history of seizures, including childhood febrile seizures
• Any condition possibly affecting drug absorption

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: PF-04802540

Drug: PF-04802540

B

Experimental group

Treatment:

Drug: PF-04802540

Drug: PF-04802540

C

Placebo Comparator group

Treatment:

Drug: Placebo