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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01091272
First received: March 18, 2010
Last updated: September 17, 2010
Last verified: September 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091272

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  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 August 26, 2014