Pharmacokinetics of Benapenem in Subjects With Renal Impairment

NCT ID: NCT04476407

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-10-21

Brief Summary

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)

Conditions

Complicated Urinary Tract Infection; Cuti

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G1

subjects with nomal renal function

Group Type: EXPERIMENTAL

benapenem

Intervention Type: DRUG

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

G2

subjects with mild renal impairment

Group Type: EXPERIMENTAL

benapenem

Intervention Type: DRUG

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

G3

subjects with moderate renal impairment

Group Type: EXPERIMENTAL

benapenem

Intervention Type: DRUG

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

Interventions

benapenem

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

Intervention Type: DRUG

benapenem

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

Intervention Type: DRUG

benapenem

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

5081-I-1004

Identifier Type: -

Identifier Source: org_study_id