Effect of renal impairment on the pharmacokinetics of prucalopride: a single- dose open-label Phase I study.

ABSTRACT:

Objective

To evaluate the pharmacokinetics of prucalopride in individuals with renal impairment (RI).

Methods

This open-label Phase I study (ClinicalTrials.gov identifier: NCT01674192) enrolled men and women aged 18-75 years who were classified by renal function: normal renal function (creatinine clearance ≥ 80 mL/min/1.73 m²), mild RI (50-79 mL/min/1.73 m²), moderate RI (25-49 mL/min/1.73 m²), and severe RI (≤ 24 mL/min/1.73 m²). All received a single oral dose of prucalopride 2 mg.

Results

Thirty-four individuals (normal renal function: 10; mild RI: 8; moderate RI: 7; severe RI: 9) received prucalopride. In all groups, maximum plasma concentration was reached within 2-4 hours. There was no significant difference in exposure (area under the plasma concentration-time

SUBMITTER: Smith WB 

PROVIDER: S-EPMC3529624 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature