Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845
Phase 1
Terminated
- Conditions
- Healthy Volunteers
- Interventions
- Drug: PF 03882845 and Placebo
- Registration Number
- NCT00856258
- Lead Sponsor
- Pfizer
- Brief Summary
To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 PF 03882845 and Placebo Cohort 1 completed. Cohort 2 PF 03882845 and Placebo Cohort 2 not studied Cohort 3 PF 03882845 and Placebo Cohort 3 not studied Cohort 4 PF 03882845 and Placebo Cohort 4 not studied
- Primary Outcome Measures
Name Time Method 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
Name Time Method Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10. 14 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States