Clinical trial NCT04476407: Pharmacokinetics of Benapenem in Subjects With Renal Impairment
Official title: "Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Complicated Urinary Tract Infection; Cuti
Lead sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Area under the plasma concentration-time curve
timeFrame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
measure: Area under the plasma concentration-time curve
timeFrame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
measure: Maximum observed plasma concentration(Cmax)
timeFrame: predose and 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 hours postdose
measure: Observed terminal elimination half-life (T1/2)
timeFrame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
measure: Total body clearance (CLt)
timeFrame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
measure: Apparent volume of distribution (Vz)
timeFrame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
measure: Cumulative urine exeretion
timeFrame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
measure: Renal clearance (CLr)
timeFrame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
measure: Metabolite-to-parent ratio of AUC0-inf
timeFrame: predose, 0.5, 1.25, 1.5, 2, 3, 5, 8, 12, 24, 48 and 72 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
Study officials:
References: