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Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

Last updated on December 1, 2019

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Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
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

- Adult healthy male and/or female (of non child bearing potential) subjects.

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

- Subjects with clinically significant systemic and laboratory abnormalities.

- Subjects with clinically significant infections within the past 3 months.

- Women of child-bearing potential.

NCT01405118
Pfizer
Completed
Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Official Title  ICMJE A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Brief SummaryThis study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of metformin, a probe drug for organic cationic transport.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: Metformin/CP-690,550
Single oral 500 mg dose of metformin on Days 1 and 4 and multiple oral 30 mg doses of CP-690,550 every 12 hours on Days 2-4.
Study Arms  ICMJE Experimental: Metformin/CP-690,550
Intervention: Drug: Metformin/CP-690,550
Publications *Klamerus KJ, Alvey C, Li L, Feng B, Wang R, Kaplan I, Shi H, Dowty ME, Krishnaswami S. Evaluation of the potential interaction between tofacitinib and drugs that undergo renal tubular secretion using metformin, an in vivo marker of renal organic cation transporter 2. Clin Pharmacol Drug Dev. 2014 Nov;3(6):499-507. doi: 10.1002/cpdd.120. Epub 2014 May 23.


*   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
Estimated Enrollment  ICMJE
 (submitted: July 27, 2011)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion DateJuly 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult healthy male and/or female (of non child bearing potential) subjects.

Exclusion Criteria:

  • Subjects with clinically significant systemic and laboratory abnormalities.
  • Subjects with clinically significant infections within the past 3 months.
  • Women of child-bearing 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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01405118
Other Study ID Numbers  ICMJE A3921143
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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2011

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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