Pharmacokinetics of Benapenem in Subjects With Renal Impairment

NCT04476407 | Completed Phase 1

• 1 other identifier: 5081-I-1004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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

  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

  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

  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

  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

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

• Renal clearance (CLr)

  Renal clearance (CLr) of Benapenem and its metabolite

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

• Metabolite-to-parent ratio of AUC0-inf

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

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

Study Arms (3)

G1

EXPERIMENTAL

subjects with nomal renal function

Drug: benapenem

G2

EXPERIMENTAL

subjects with mild renal impairment

Drug: benapenem

G3

EXPERIMENTAL

subjects with moderate renal impairment

Drug: benapenem

Interventions

benapenem DRUG

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

G1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~75 years old
• \. BMI 17 to 30 kg/m2
• \. No known diseases or significant abnormalities on physical exam (subjects with normal renal function only)
• \. eGFR ≥ 90 mL/min/1.73m2 (subjects with normal renal function only)
• \. 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)

You may not qualify if:

• \. Hypersensitivity to any of the beta-lactam antibiotics
• Conditions or disease that may interfere with the evaluation of study drug
• \. Acute disease requiring antibiotics within 30 days prior to administration, or a fever within 7 days prior to administration;
• \. Drug abuse in 2 years
• \. A blood donation or more than 400 ml of blood loss within 3 months

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Interventions

benapenem

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: June 15, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: July 20, 2020

Record last verified: 2019-04

Locations

CN (1)