NCT04787562

Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function

A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF XNW4107, IMIPENEM AND CILASTATIN ADMINISTERED CONCURRENTLY AS INTRAVENOUS INFUSION TO SUBJECTS WITH VARIOUS DEGREES OF RENAL FUNCTION

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Evopoint Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label study to assess the PK, safety and tolerability of XNW4107, imipenem and cilastatin administered by 60-minute (60-min) IV infusion to adults with various degrees of renal insufficiency as compared to subjects with normal renal function.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	XNW4107, Imipenem/Cilastatin	Drug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
DRUG	XNW4107, Imipenem/Cilastatin	Drug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
DRUG	XNW4107, Imipenem/Cilastatin	Drug: XNW4107 250mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose
DRUG	XNW4107, Imipenem/Cilastatin	Drug: XNW4107 100mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose
DRUG	XNW4107, Imipenem/Cilastatin	Drug: XNW4107 100mg IV over 60 minutes as a single dose Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose

Timeline

• Start date: 2021-02-25
• Primary completion: 2021-10-30
• Completion: 2022-02-28
• First posted: 2021-03-08
• Last updated: 2023-02-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study