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A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-04455242
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00956956
B1071002

Details and patient eligibility

About

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of PF-04455242 on serum prolactin concentration will be explored.

Enrollment

36 patients

Sex

All

Ages

21 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and/or female subjects without childbearing potential between the ages of 21 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).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups, including a placebo group

PF-04455242 treatment
Experimental group
Treatment:
Drug: PF-04455242
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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