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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00856258
• Other study ID #: B0171002
• Status: Terminated
• Phase: Phase 1
• First received: March 3, 2009
• Last updated: December 22, 2009
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10.		14 days	No

External Links

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