Phase 1
Completed N=32
PF-04634817 Renal Impairment Study
Source: ClinicalTrials.gov NCT01791855 ↗Enrolled (actual)
32
Serious AEs
3.2%
Results posted
Mar 2024
Primary outcomePrimary: Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)] — 1294; 1399; 2024; 2860 Nanogram*hour/milliliter (ng*h/mL)
Summary
Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)] |
1294; 1399; 2024; 2860 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
1467; 1575; 2610; 3845 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] |
1473; 1584; 2611; 3877 | — |
| PRIMARY Apparent Oral Clearance (CL/F) |
565.8; 526.8; 319.2; 215.2 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
124.6; 111.4; 123.7; 132.3 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.01; 2.50; 2.00; 3.00 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) |
1453; 1808; 1162; 742.3 | — |
| PRIMARY Plasma Decay Half-Life (t1/2) |
31.01; 43.94; 43.57; 44.94 | — |
| SECONDARY Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48) |
9303000; 5993000; 4997000; 3097000 | — |
| SECONDARY Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%) |
18.61; 12.00; 9.989; 6.193 | — |
| SECONDARY Renal Clearance Over a 48-hour Interval(CLr48) |
119.8; 71.40; 41.13; 18.05 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female (non child bearing potential aged 18-75 years
- Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)
Exclusion Criteria
- Subjects with acute renal failure
- Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
- Abnormal ECG at screening
Data sourced from ClinicalTrials.gov (NCT01791855). 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.