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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04995274

• Registration Number: NCT01091272
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-24
• Study Start: 2010-04
• Primary Completion: 2010-08
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	PF-04995274	Single dose 3 period interleaved cross-over with placebo substitution
Optional Cohort 4	PF-04995274	Single dose 3 period cross-over with placebo substitution
Cohort 3	PF-04995274	Single dose 4 period cross-over, placebo insertion, with food effect
Cohort 2	PF-04995274	Single dose 4 period interleaved cross-over, placebo substitution, with food effect

Primary Outcome Measures

Name	Time	Method
Safety Endpoints (AE's, Vital signs (supine & standing BP, PR), Triplicate ECG, 8 hours of cardiac telemetry postdose, Clinical safety laboratory endpoints, Digit Symbol Substitution Test (DSST), Drug Effect Questionnaire (DEQ), Clinical	up to 21 days post dose
examinations)	up to 21 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.	up to 7 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.	up to 7 days post dosing

Secondary Outcome Measures

Name	Time	Method
Plasma aldosterone concentrations	through 1 day post dosing

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium