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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091272
• Other study ID #: B1661001
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2010
• Last updated: September 17, 2010
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• PF-04995274
Planned single PO 120mg and 210mg doses of PF-04995274
• PF-04995274
single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	examinations)		up to 21 days post dose	Yes
Primary	Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.		up to 7 days post dose	No
Primary	Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.		up to 7 days post dosing	No
Secondary	Plasma aldosterone concentrations		through 1 day post dosing	No

External Links

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