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

NCT00856258 | Terminated Phase 1

• 1 other identifier: B0171002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Multiple dose in healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  14 days

Study Arms (4)

Cohort 1

PLACEBO COMPARATOR

Cohort 1 completed.

Drug: PF 03882845 and Placebo

Cohort 2

PLACEBO COMPARATOR

Cohort 2 not studied

Drug: PF 03882845 and Placebo

Cohort 3

PLACEBO COMPARATOR

Cohort 3 not studied

Drug: PF 03882845 and Placebo

Cohort 4

PLACEBO COMPARATOR

Cohort 4 not studied

Drug: PF 03882845 and Placebo

Interventions

PF 03882845 and Placebo DRUG

The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 5, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

US (1)