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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01405118
First received: July 7, 2011
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of metformin, a probe drug for organic cationic transport.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Metformin/CP-690,550
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin [ Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • Cmax (Maximum plasma concentration) of metformin [ Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • Clr (Renal clearance) of metformin [ Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin [ Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • t½ (Terminal half-life) of metformin [ Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • Tmax (Time for maximum plasma concentration) of metformin [ Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin [ Time Frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin [ Time Frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • Clr (Renal clearance) over each collection interval for metformin [ Time Frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4 ] [ Designated as safety issue: No ]
  • CP-690,550 plasma concentration at 2 hours postdose [ Time Frame: 2 hrs after first CP-690,550 dose on Day 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin/CP-690,550 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405118

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01405118     History of Changes
Other Study ID Numbers: A3921143
Study First Received: July 7, 2011
Last Updated: August 17, 2011
Health Authority: Belgium: Belgian Competent Authority

Keywords provided by Pfizer:
Drug-Drug Interaction Healthy Volunteers CP-690
550 Metformin

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014