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Completed

NCT Number: NCT04476407

Pharmacokinetics of Benapenem in Subjects With Renal Impairment

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)

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Key information

Conditions

Complicated Urinary Tract Infection; Cuti

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200092, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benapenem

Drug

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

Primary outcomes

  1. Area under the plasma concentration-time curve

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

  2. Area under the plasma concentration-time curve

    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 from time 0 to infinity ( AUC0-inf ) of benapenem and the metabolite

  3. Maximum observed plasma concentration(Cmax)

    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) of benapenem and the metabolite

  4. Observed terminal elimination half-life (T1/2)

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

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

  5. Total body clearance (CLt)

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

    Total body clearance (CLt) of benapenem

  6. Apparent volume of distribution (Vz)

    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) based on the terminal phase of benapenem

  7. Cumulative urine exeretion

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

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

  8. Renal clearance (CLr)

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

    Renal clearance (CLr) of Benapenem and its metabolite

  9. Metabolite-to-parent ratio of AUC0-inf

    Time frame: 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 (MR)

Sponsors and collaborators

Lead sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2020
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.