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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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