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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00856258
First received: March 3, 2009
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: PF 03882845 and Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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). [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 13 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Cohort 2
Cohort 2 not studied
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 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 will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856258

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00856258     History of Changes
Other Study ID Numbers: B0171002
Study First Received: March 3, 2009
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Multiple dose in healthy volunteers

ClinicalTrials.gov processed this record on September 22, 2014