Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845

Study Overview
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Brief Summary
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To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.

Detailed Description
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The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.

Official Title
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A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PF 03882845 and Placebo
* Drug: PF 03882845 and Placebo
* Drug: PF 03882845 and Placebo
* Drug: PF 03882845 and Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects of non-childbearing 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 pulse rate measurement, 12 lead ECG and clinical laboratory tests. An informed consent document signed and dated by the subject or a legally acceptable representative. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Evidence or history of clinically significant disease, allergy or clinical findings at screening. A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3. Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. Pregnant or nursing females; females of childbearing potential.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cohort 1<br>Cohort 1 completed. | Drug: PF 03882845 and Placebo<br>* The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.<br>|
| Placebo Comparator: Cohort 2<br>Cohort 2 not studied | Drug: PF 03882845 and Placebo<br>* The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.<br>|
| Placebo Comparator: Cohort 3<br>Cohort 3 not studied | Drug: PF 03882845 and Placebo<br>* The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.<br>|
| Placebo Comparator: Cohort 4<br>Cohort 4 not studied | Drug: PF 03882845 and Placebo<br>* The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Dose PK: Cmax, Tmax, and AUCtau; Multiple Dose PK (Assumed Steady State): Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd). |  | 13 days | 
| Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, and electrocardiograms (ECGs). |  | 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10. |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple dose in healthy volunteers