Clinical trial NCT01710020: Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Official title: Phase 1, Open-Label Study Of The Pharmacokinetics, Non-Renal Clearance And Dialyzability Of CP-690,550 In Subjects With End-Stage Renal Disease Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End-Stage Renal Disease
Hemodialysis
Keywords: CP-690
550
pharmacokinetics
end-stage renal disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Subjects with end-stage renal disease
* Subjects need hemodialysis 3 times weekly

Exclusion Criteria:

* Subjects with evidence or history of clinically significant disease, excluding those common for subjects with End-Stage Renal Disease (ESRD).
* Subjects with any condition possibly affecting drug absorption.
* Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Oral Clearance (CLpo)
timeFrame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1
measure: Dialyser Clearance (CL HD) From 0 to 1 Hour
timeFrame: 0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2
measure: Dialyser Clearance (CL HD) From 1 to 2 Hour
timeFrame: 1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2
measure: Dialyser Clearance (CL HD) From 2 to 3 Hour
timeFrame: 2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2
measure: Dialyser Clearance (CL HD) From 3 to 4 Hour
timeFrame: 3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2
Secondary outcomes:
measure: Fraction of Unbound Drug (fu)
timeFrame: 2 hours post-dose in Period 1
Other outcomes:
measure: Overall Dialyser Clearance (CL HD)
timeFrame: 0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2
measure: Dialyser Clearance (CL HD) From 3 to 3.5 Hour
timeFrame: 3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2
Locations:
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.