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

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

To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF 03882845 and Placebo; Drug: PF 03882845 and Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 3, 2009
• First Submitted That Met QC Criteria: March 3, 2009
• First Posted (Estimate): March 5, 2009

Study Record Updates

• Last Update Posted (Estimate): December 23, 2009
• Last Update Submitted That Met QC Criteria: December 22, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Multiple dose in healthy volunteers
• Other Study ID Numbers: B0171002