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Clinical Trial Details

Trial ID: L1013
Source ID: NCT01710020
Associated Drug: Cp-690,550
Title: Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01710020/results
Conditions: End-Stage Renal Disease|Hemodialysis
Interventions: DRUG: CP-690,550
Outcome Measures: Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)], AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)., 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast), 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Maximum Observed Plasma Concentration (Cmax), 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Time to Reach Maximum Observed Plasma Concentration (Tmax), 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Plasma Decay Half-Life (t1/2), Plasma decay half-life is the time measured for the plasma concentration to decrease by one half., 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Oral Clearance (CLpo), Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC., 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Dialyser Clearance (CL HD) From 0 to 1 Hour, Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm)., 0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2|Dialyser Clearance (CL HD) From 1 to 2 Hour, Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm)., 1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2|Dialyser Clearance (CL HD) From 2 to 3 Hour, Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm)., 2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2|Dialyser Clearance (CL HD) From 3 to 4 Hour, Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm)., 3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2 | Secondary: Fraction of Unbound Drug (fu), Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration., 2 hours post-dose in Period 1 | Other: Overall Dialyser Clearance (CL HD), Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm)., 0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Dialyser Clearance (CL HD) From 3 to 3.5 Hour, Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm)., 3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2003-02
Completion Date: 2003-06
Results First Posted: 2012-12-18
Last Update Posted: 2012-12-18
Locations: Pfizer Investigational Site, Orlando, Florida, 32806, United States|Pfizer Investigational Site, Minneapolis, Minnesota, 55404, United States
URL: https://clinicaltrials.gov/show/NCT01710020