Pharmacokinetics of Benapenem in Subjects With Renal Impairment

Sihuan Pharmaceutical Holdings Group Ltd.18 enrolled

Overview

This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Complicated Urinary Tract Infection; Cuti

Interventions

benapenemDRUG

single-dose Benapenem 1.0mg(iv), 60min infusion

benapenemDRUG

single-dose Benapenem 1.0mg(iv), 60min infusion

benapenemDRUG

single-dose Benapenem 1.0mg(iv), 60min infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 1.18\~75 years old * 2\. BMI 17 to 30 kg/m2 * 3\. No known diseases or significant abnormalities on physical exam (subjects with normal renal function only) * 4\. eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only) * 5\. eGFR 30 to 59 mL/min/1.73m2 (subjects with mild renal impairment only); eGFR 60 to 89 mL/min/1.73m2 (subjects with moderate renal impairment only) Exclusion Criteria: * 1\. Hypersensitivity to any of the beta-lactam antibiotics * 2.Conditions or disease that may interfere with the evaluation of study drug * 3\. Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration; * 4\. Drug abuse in 2 years * 5\. A blood donation or more than 400 ml of blood loss within 3 months

Locations (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve

Area under the plasma concentration-time curve from time 0 to the time of thelast quantifiable concentration (AUC0-t )of benapenem and the metabolite

Time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose

Area under the plasma concentration-time curve

Area under the plasma concentration-time curve from time 0 to infinity ( AUC0-inf ) of benapenem and the metabolite

Time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose

Maximum observed plasma concentration(Cmax)

Maximum observed plasma concentration(Cmax) of benapenem and the metabolite

Time frame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose

Observed terminal elimination half-life (T1/2)

Observed terminal elimination half-life (T1/2) of benapenem and its metabolite

Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose

Total body clearance (CLt)

Total body clearance (CLt) of benapenem

Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose

Apparent volume of distribution (Vz)

Apparent volume of distribution (Vz) based on the terminal phase of benapenem

Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose

Cumulative urine exeretion

Cumulative urine exeretion (Ae0-72h%) of benapenem and its metabolite

Time frame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose

Data from ClinicalTrials.gov

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