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Completed

NCT Number: NCT01091272

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

About this study

The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. examinations)

    Time frame: up to 21 days post dose

  3. Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.

    Time frame: up to 7 days post dose

  4. Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.

    Time frame: up to 7 days post dosing

Secondary outcomes

  1. Plasma aldosterone concentrations

    Time frame: through 1 day post dosing

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 24, 2010
Registry last updated
Sep 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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