You are here

Our science / Clinical Trials / Find a Trial / NCT01247883

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

Back to Search Print Save as PDF Bookmark Trial

NCT01247883

Last updated on November 13, 2019
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Healthy
A Study to Demonstrate the Equivalence of the Tofacitinib Oral Solution to the Tablet Formulation in Healthy Participants.
NCT04111614
All Genders
18+
Years
New Haven, Connecticut
Healthy
Study of Single Ascending Doses of PF-07081532 in Healthy Adult Participants
NCT04148209
All Genders
18+
Years
Brussels,
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061
All Genders
18+
Years
Multiple Sites
Healthy Volunteers
A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
NCT04092595
All Genders
18+
Years
Brussels, Be-bru
Descriptive Information
Brief Title  ICMJE A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04634817
    single dose, 20mg, tablet
  • Drug: PF-04634817
    single dose, 20mg, solution
Study Arms  ICMJE
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2011)		13
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2010)		14
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01247883
Other Study ID Numbers  ICMJE B1261005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Incyte Corporation
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now