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

NCT01091272 | Completed Phase 1

• 1 other identifier: B1661001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

healthy volunteer; safety; pharmacokinetic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Plasma aldosterone concentrations

  through 1 day post dosing

Study Arms (4)

Cohort 1

EXPERIMENTAL

Single dose 3 period interleaved cross-over with placebo substitution

Drug: PF-04995274

Cohort 2

EXPERIMENTAL

Single dose 4 period interleaved cross-over, placebo substitution, with food effect

Drug: PF-04995274

Cohort 3

EXPERIMENTAL

Single dose 4 period cross-over, placebo insertion, with food effect

Drug: PF-04995274

Optional Cohort 4

EXPERIMENTAL

Single dose 3 period cross-over with placebo substitution

Drug: PF-04995274

Interventions

PF-04995274 DRUG

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.

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 24, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 20, 2010

Record last verified: 2010-09

Locations

BE (1)