NCT01405118 - Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers | Crick | Crick

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

Phase 1CompletedNCT01405118

Pfizer24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

24

Conditions

Rheumatoid Arthritis

Interventions

Metformin/CP-690,550DRUG

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

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

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

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

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

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

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

Data from ClinicalTrials.gov

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