A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04995274

Study type: Interventional

Funder types: Industry

Identifiers

NCT01091272

B1661001

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

Full description

The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Pregnant or nursing women; women of childbearing potential. Female subjects must be of non childbearing potential defined by a history of surgical sterilization (eg, hysterectomy or bilateral oophorectomy) or post menopausal status (complete absence of menses for at least two consecutive years) and elevated FSH concentration in women between 45 and 55.

Trial design

28 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Single dose 3 period interleaved cross-over with placebo substitution

Treatment:

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Cohort 2

Experimental group

Description:

Single dose 4 period interleaved cross-over, placebo substitution, with food effect

Treatment:

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Cohort 3

Experimental group

Description:

Single dose 4 period cross-over, placebo insertion, with food effect

Treatment:

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Optional Cohort 4

Experimental group

Description:

Single dose 3 period cross-over with placebo substitution

Treatment:

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274

Drug: PF-04995274