A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04995274 After Administration Of Single Oral Doses To Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- PF-04995274
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
Single dose 3 period interleaved cross-over with placebo substitution
Intervention: PF-04995274
Cohort 2
Single dose 4 period interleaved cross-over, placebo substitution, with food effect
Intervention: PF-04995274
Cohort 3
Single dose 4 period cross-over, placebo insertion, with food effect
Intervention: PF-04995274
Optional Cohort 4
Single dose 3 period cross-over with placebo substitution
Intervention: PF-04995274
Outcomes
Primary Outcomes
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
Time Frame: up to 21 days post dose
examinations)
Time Frame: up to 21 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.
Time Frame: up to 7 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.
Time Frame: up to 7 days post dosing
Secondary Outcomes
- Plasma aldosterone concentrations(through 1 day post dosing)