Phase 1
N=24
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01740362 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] — 268; 370; 396; 615 nanogram*hour/milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CP-690,550 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
268; 370; 396; 615 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
94.2; 87.3; 104; 111 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.75; 1.00; 0.75; 0.75 | — |
| PRIMARY Plasma Decay Half-Life (t1/2) |
2.37; 2.83; 2.88; 3.77 | — |
| PRIMARY Renal Clearance (CL R) |
113; 84.7; 27.4; 19.9 | — |
Summary
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
Eligibility Criteria
Inclusion Criteria
- Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
- Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease
Exclusion Criteria
- Kidney transplant patients
- 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 (NCT01740362). 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.