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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF 03882845 and Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856258

B0171002

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10 participants in 4 patient groups, including a placebo group

Cohort 1

Placebo Comparator group

Description:

Cohort 1 completed.

Treatment:

Drug: PF 03882845 and Placebo

Cohort 2

Placebo Comparator group

Description:

Cohort 2 not studied

Treatment:

Drug: PF 03882845 and Placebo

Cohort 3

Placebo Comparator group

Description:

Cohort 3 not studied

Treatment:

Drug: PF 03882845 and Placebo

Cohort 4

Placebo Comparator group

Description:

Cohort 4 not studied

Treatment:

Drug: PF 03882845 and Placebo