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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01247883
Pfizer
Completed
A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

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A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
A Two Period, 2 Sequence Crossover To Establish The Relative Bioavailability Of A Single Pf-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-04634817
    single dose, 20mg, tablet
  • Drug: PF-04634817
    single dose, 20mg, solution
  • Active Comparator: single dose PF-04634817 tablet
    subjects receive a single dose of PF-04634817 as a tablet
    Intervention: Drug: PF-04634817
  • Active Comparator: single dose PF-04634817 solution
    subjects receive a single dose of PF-04634817 as a solution
    Intervention: Drug: PF-04634817
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2010
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01247883
B1261005
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Incyte Corporation
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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