NCT02840812

Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function

Status unknown Phase 1 Last updated 1 April 2018

What this trial tests

Phase 1 trial testing Nemonoxacin in Kidney Dysfunction in 24 participants. Status unknown.

Timeline

5 April 2017

Primary endpoint
1 January 2019

1 January 2019

Quick facts

Lead sponsor	Zhejiang Medicine Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	24
Start date	5 April 2017
Primary completion	1 January 2019
Estimated completion	1 January 2019
Sites	1 location across China

Drugs / interventions tested

• Nemonoxacin (NEMONOXACIN) — full drug profile →

Conditions studied

• Kidney Dysfunction — all drugs for Kidney Dysfunction →

Sponsor

Zhejiang Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Kidney Dysfunction. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function:maximum plasma drug concentration ( Cmax)
  Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
• Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: time at which maximum plasma concentration is observed (Tmax)
  Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
• Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: area under the plasma concentration vs. time curve (AUC0-t and AUC0-∞)
  Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
• Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: elimination half-life (t1/2)
  Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
• Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: mean dissolution time(MRT)
  Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
• Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in severe impaired renal Function: total clearance of the drug from plasma (CLz/F)
  Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing

Sponsor's own description

This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated) subjects in age, gender and weight as parallel control, which matches healthy with normal renal function according to the of subjects with impaired renal function as, after enrollment of subjects with severe impaired renal function (eGFR≤30mL/min/1.73m2，CKD-EPI estimated). Renal function impaired group and control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before and after the administration to perform pharmacokinetic analysis and safety observation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
   Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191