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Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function

NCT04787562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-02-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Evopoint Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Le · Evopoint Biosciences Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-10-30
Completion
2022-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787562 on ClinicalTrials.gov