A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01091272
First received: March 18, 2010
Last updated: September 17, 2010
Last verified: September 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-04995274 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | 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 |
Further study details as provided by Pfizer:
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 [ Time Frame: up to 21 days post dose ] [ Designated as safety issue: Yes ]
- examinations) [ Time Frame: up to 21 days post dose ] [ Designated as safety issue: Yes ]
- Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit. [ Time Frame: up to 7 days post dose ] [ Designated as safety issue: No ]
- Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit. [ Time Frame: up to 7 days post dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma aldosterone concentrations [ Time Frame: through 1 day post dosing ] [ Designated as safety issue: No ]
| Enrollment: | 28 |
| Study Start Date: | April 2010 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01091272 History of Changes |
| Other Study ID Numbers: | B1661001 |
| Study First Received: | March 18, 2010 |
| Last Updated: | September 17, 2010 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Keywords provided by Pfizer:
|
healthy volunteer safety pharmacokinetic |
ClinicalTrials.gov processed this record on May 21, 2013