A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Single dose 3 period interleaved cross-over with placebo substitution |
Drug: PF-04995274
Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
|
| Experimental: Cohort 2 Single dose 4 period interleaved cross-over, placebo substitution, with food effect |
Drug: PF-04995274
Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
|
| Experimental: Cohort 3 Single dose 4 period cross-over, placebo insertion, with food effect |
Drug: PF-04995274
Planned single PO 120mg and 210mg doses of PF-04995274
|
| Experimental: Optional Cohort 4 Single dose 3 period cross-over with placebo substitution |
Drug: PF-04995274
single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data
|
Outcome Measures
Primary Outcome Measures
- 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
- Plasma aldosterone concentrations [through 1 day post dosing]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Bruxelles | Belgium | 1070 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B1661001