NCT03776539

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eloxx Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Phase 1 - Pharmacokinetics in Patients with Impaired Renal Function

Detailed 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.

Conditions

• Impaired Renal Function

Interventions

Type	Name	Description
DRUG	ELX-02	ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment.

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-07-30
• Completion: 2019-08-07
• First posted: 2018-12-14
• Last updated: 2021-04-13
• Results posted: 2021-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study