Phase 4
Completed N=18
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function
Source: ClinicalTrials.gov NCT00717067 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast) — 7356.3; 9502.1; 6496.0; 1320.7 ng*hr/mL
Summary
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast) |
7356.3; 9502.1; 6496.0; 1320.7; 4255.5; 2636.5 | — |
| PRIMARY AUCtau |
5341.4; 8118.7; 6193.3 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
950.91; 1150.74; 674.20; 335.60; 801.16; 576.7 | — |
| SECONDARY Plasma Protein Binding |
19.7; 15.3; 18.1; 14.6; 19.2; 18.2 | — |
| SECONDARY Area Under the Time Curve From 0 to Infinity (AUCinf) |
1348.4; 4367.7; 2677.4; 2805.5 | — |
| SECONDARY Time of First Occurrence (Tmax) |
1.000; 1.500; 2.000; 2.500; 2.500; 3.000 | — |
| SECONDARY Half-life (t1/2) |
14.22; 16.84; 16.99; 14.36; 17.29; 15.03 | — |
| SECONDARY Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function |
105.7; 77.2; 62.5; 110.0; 26.6 | — |
| SECONDARY Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae |
41.6; 39.1; 24.9; 10.8; 8.4 | — |
| SECONDARY Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD |
36.42 | — |
| SECONDARY Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals |
1; 0; 0; 1; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Stable Renal Function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks.
- Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive.
- Total body weight >50 kg (110 lbs).
- Male or female subjects between the ages of 18 and 85 years.
Exclusion Criteria
- Subjects with acute renal disease and/or history of renal transplant.
- Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic.
- Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.
Data sourced from ClinicalTrials.gov (NCT00717067). 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.