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

NCT01405118 | Completed Phase 1

• 1 other identifier: A3921143
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Drug-Drug Interaction Healthy Volunteers CP-690; 550 Metformin

Outcome Measures

Primary Outcomes (3)

• AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin

  0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

• Cmax (Maximum plasma concentration) of metformin

  0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

• Clr (Renal clearance) of metformin

  0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

Secondary Outcomes (7)

• AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin

  0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

• t½ (Terminal half-life) of metformin

  0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

• Tmax (Time for maximum plasma concentration) of metformin

  0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4

• Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin

  0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4

• Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin

  0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4

Study Arms (1)

Metformin/CP-690,550

EXPERIMENTAL

Drug: Metformin/CP-690,550

Interventions

Metformin/CP-690,550 DRUG

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.

Metformin/CP-690,550

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Subjects with clinically significant systemic and laboratory abnormalities.
• Subjects with clinically significant infections within the past 3 months.
• Women of child-bearing potential.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Publications (1)

• 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.

  PMID: 27129125 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 29, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 18, 2011

Record last verified: 2011-08

Locations

BE (1)