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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01405118
• Date of registration: 07/07/2011
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
• Scientific 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
• Date of first enrolment: June 2011
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01405118
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Metformin/CP-690,550

Primary Outcome(s)

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]

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]

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 Outcome(s)

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]

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]

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]

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]

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]

CP-690,550 plasma concentration at 2 hours postdose [Time Frame: 2 hrs after first CP-690,550 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]

Secondary ID(s)

A3921143

Source(s) of Monetary Support

Please refer to primary and secondary sponsors