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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00856258
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF 03882845 and Placebo; Drug: PF 03882845 and Placebo; Drug: PF 03882845 and Placebo; Drug: PF 03882845 and Placebo	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, 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
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00856258
• Other Study ID Numbers: B0171002
• First Posted: Mar 5, 2009
• Last Update Posted: Dec 23, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Multiple dose in healthy volunteers

Study Results

No Results Posted as of Dec 23, 2009