Pharmacokinetics of Benapenem in Subjects With Renal Impairment

Sihuan Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Complicated Urinary Tract Infection; Cuti

Treatments: Drug: benapenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT04476407

5081-I-1004

Details and patient eligibility

About

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)

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

G1

Experimental group

Description:

subjects with nomal renal function

Treatment:

Drug: benapenem

Drug: benapenem

Drug: benapenem

G2

Experimental group

Description:

subjects with mild renal impairment

Treatment:

Drug: benapenem

Drug: benapenem

Drug: benapenem

G3

Experimental group

Description:

subjects with moderate renal impairment

Treatment:

Drug: benapenem

Drug: benapenem

Drug: benapenem