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Pharmacokinetics of Benapenem in Subjects With Renal Impairment

Primary Purpose

Complicated Urinary Tract Infection; Cuti

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

benapenem

About this trial

This is an interventional treatment trial for Complicated Urinary Tract Infection; Cuti

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Shanghai Tongji Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

subjects with nomal renal function

subjects with mild renal impairment

subjects with moderate renal impairment

Outcomes

Primary Outcome Measures

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

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

Maximum observed plasma concentration(Cmax)

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

Observed terminal elimination half-life (T1/2)

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

Total body clearance (CLt)

Total body clearance (CLt) of benapenem

Apparent volume of distribution (Vz)

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

Cumulative urine exeretion

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

Renal clearance (CLr)

Renal clearance (CLr) of Benapenem and its metabolite

Metabolite-to-parent ratio of AUC0-inf

Metabolite-to-parent ratio of AUC0-inf (MR)

Secondary Outcome Measures

Full Information

NCT ID

NCT04476407

First Posted

July 15, 2020

Last Updated

July 15, 2020

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04476407

Brief Title

Pharmacokinetics of Benapenem in Subjects With Renal Impairment

Official Title

"Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

June 15, 2019 (Actual)

Primary Completion Date

October 21, 2019 (Actual)

Study Completion Date

October 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complicated Urinary Tract Infection; Cuti

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

subjects with nomal renal function

Arm Title

Arm Type

Experimental

Arm Description

subjects with mild renal impairment

Arm Title

Arm Type

Experimental

Arm Description

subjects with moderate renal impairment

Intervention Type

Drug

Intervention Name(s)

benapenem

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

benapenem

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

benapenem

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the plasma concentration-time curve

Description

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

Title

Area under the plasma concentration-time curve

Description

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

Title

Maximum observed plasma concentration(Cmax)

Description

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

Title

Observed terminal elimination half-life (T1/2)

Description

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

Time Frame