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A Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02

Impaired Renal Function Clinical Trial

Official title:
A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics of ELX-02

Clinical Trial Summary

Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function

Clinical Trial Description

The study is a two-center, Phase 1, open-label, single-dose, one-period, four-parallel-group, PK study in subjects with various severities of renal dysfunction and healthy volunteers. Subjects will be categorized in 4 groups: Group 1: subjects with mild renal impairment Group 2: subjects with moderate renal impairment Group 3: subjects with severe renal impairment Group 4 (control group): subjects with normal renal function The mild (group 1) and moderate (group 2) patients with renal disease will be dosed first, in a parallel fashion. At this point, interim PK analyses will be performed and a safety committee composed of Sponsor and Contract Research Organization (CRO) members will jointly review the PK data before dosing the patients with severe renal disease (group 3). Control subjects (group 4) will be recruited after the recruitment of groups 1 to 3. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03776539
Study type Interventional
Source Eloxx Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 4, 2019
Completion date August 7, 2019
View Details
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