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

Phase 1CompletedNCT00772512

Taisho Pharmaceutical Co., Ltd.13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-04802540DRUG

5 mg capsule, single dose

PF-04802540DRUG

15 mg capsule, single dose

PlaceboDRUG

Placebo capsule, single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New York, New York, United States

Outcomes

Primary Outcomes

REM sleep percentage

Time frame: 1 day

Secondary Outcomes

REM sleep latency

Time frame: 1 day

Beta EEG power

Time frame: 1 day

Plasma concentrations of PF-04802540 and its metabolite, PF-04831035

Time frame: 2 days

Data from ClinicalTrials.gov

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