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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224682

Enrollment

Registered

2019-05-10

Start date

2018-06-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal impairment

Interventions

investigational material(s) Generic name etc : PXL008 INN of investigational material : Imeglimin Therapeutic category code : 3-- Agents affecting metabolism Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
pharmacokinetics pharmacokinetics	—

Secondary

Measure	Time frame
safety safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026