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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405118
• Other study ID #: A3921143
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2011
• Last updated: August 17, 2011
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Belgian Competent Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Clr (Renal clearance) over each collection interval for metformin		0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4	No
Secondary	CP-690,550 plasma concentration at 2 hours postdose		2 hrs after first CP-690,550 dose on Day 4	No

External Links

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