Clinical trial NCT01405118: Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Drug-Drug Interaction Healthy Volunteers CP-690
550 Metformin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin
timeFrame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
measure: Cmax (Maximum plasma concentration) of metformin
timeFrame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
measure: Clr (Renal clearance) of metformin
timeFrame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
Secondary outcomes:
measure: AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin
timeFrame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
measure: t½ (Terminal half-life) of metformin
timeFrame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
measure: Tmax (Time for maximum plasma concentration) of metformin
timeFrame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
measure: Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin
timeFrame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4
measure: Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin
timeFrame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4
measure: Clr (Renal clearance) over each collection interval for metformin
timeFrame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4
measure: CP-690,550 plasma concentration at 2 hours postdose
timeFrame: 2 hrs after first CP-690,550 dose on Day 4
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.