The Pharmacokinetics study of Imeglimin (PXL008) in Japanese Subjects with Renal Impairment

Phase 1

Completed

• Conditions: Renal impairment

• Registration Number: JPRN-jRCT2080224682
• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.

Brief Summary

The Cmax and AUC increased in association with the degree of renal impairment. No adverse events were observed and tolerability was confirmed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-10
• Study Completion: 2019-10-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Main inclusion criteria:
-Subjects who meet any of the following eGFR (mL/min/1.73 m2) at screening and the day before study drug administration
Normal Renal Function: more than or equal to 90
Mild renal impairment: more than or equal to 60, less than 90
Moderate renal impairment: more than or equal to 30, less than 60
Severe renal impairment: more than or equal to 15, less than 30
-Subjects who require no dialysis

Exclusion Criteria

Main exclusion criteria:
-Subjects who are diagnosed with an acute deterioration in renal function within 4 weeks (28 days) before screening based on symptoms or laboratory tests.
-Subjects with hemoglobin less than 8.0 g/dL at screening.
-Subjects who have received peritoneal dialysis or hemodialysis between screening and the day before study drug administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified