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A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-04634817

Study type

Interventional

Funder types

Industry

Identifiers

NCT01247883
B1261005

Details and patient eligibility

About

This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.

Enrollment

13 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
  • Nursing females;
  • Females of childbearing potential.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

13 participants in 2 patient groups

single dose PF-04634817 tablet
Active Comparator group
Description:
subjects receive a single dose of PF-04634817 as a tablet
Treatment:
Drug: PF-04634817
Drug: PF-04634817
single dose PF-04634817 solution
Active Comparator group
Description:
subjects receive a single dose of PF-04634817 as a solution
Treatment:
Drug: PF-04634817
Drug: PF-04634817

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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