Phase 1
Completed N=12
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Source: ClinicalTrials.gov NCT01710020 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] — 396 nanogram*hour/milliliter (ng*hr/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
396 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
385 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
106 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.5 | — |
| PRIMARY Plasma Decay Half-Life (t1/2) |
3.46 | — |
| PRIMARY Oral Clearance (CLpo) |
501 | — |
| PRIMARY Dialyser Clearance (CL HD) From 0 to 1 Hour |
311 | — |
| PRIMARY Dialyser Clearance (CL HD) From 1 to 2 Hour |
325 | — |
| PRIMARY Dialyser Clearance (CL HD) From 2 to 3 Hour |
332 | — |
| PRIMARY Dialyser Clearance (CL HD) From 3 to 4 Hour |
292 | — |
| SECONDARY Fraction of Unbound Drug (fu) |
0.390 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01710020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.