Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects
Primary Purpose
PK in Patients With Various Degrees of Renal Impairment
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
cefepime/AAI101
Sponsored by
About this trial
This is an interventional other trial for PK in Patients With Various Degrees of Renal Impairment
Eligibility Criteria
Main Inclusion Criteria
- Adult male or female subjects age 18 to 70 years, inclusive
- BMI 18.0 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2) Subjects with Renal Impairment (in addition)
- Stable renal impairment, defined as no clinically significant change in disease status, as judged by the Investigator Healthy Subjects (in addition)
- Subjects with normal renal function as evidenced by CLcr
- Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality OR Subject has a stable disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control.
Sites / Locations
- Pharmaceutical Research Associates CZ, s.r.o.
- PRA Magyarország Kft Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cefepime/AAI101 combination
Arm Description
Investigational drug
Outcomes
Primary Outcome Measures
The maximum plasma concentration (Cmax) of cefepime and AAI101
Cmax will be compared before and after administration of a single dose of cefepime/AAI101
AUC0-inf: area under the concentration-time curve (AUC) from time 0 extrapolated to infinity of cefepime and AAI101
AUC0-inf will be compared before and after administration of a single dose of cefepime/AAI101
Secondary Outcome Measures
The number of volunteers with adverse events as a measure of safety and tolerability
Assessments will be made via recording of AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03680352
Brief Title
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects
Official Title
Phase 1, Open-label, Parallel Group, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AAI101 With Cefepime in Subjects With Varying Degrees of Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allecra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 1, multi-center, open-label, PK and safety study of a single dose of AAI101 in combination with cefepime in male and female subjects with mild renal impairment (Group 1, n = 6), moderate renal impairment (Group 2, n = 6), severe renal impairment (Group 3, n = 6), ESRD requiring dialysis (Group 4, n = 6), and normal renal function (Group 5, n = 6) as defined using the estimated value for creatinine clearance (CLcr) at Screening.
The study consists of a 28-day screening period, followed by a single dose administration of AAI101 in combination with cefepime antibiotic on Day 1, an in house period (assessment period) and follow-up visit. All subjects will be confined to the study site from Day -1 (the day before dosing) until the morning of Day 3. The follow-up visits will occur on Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on Day 14 (±2 days).
Group 4 (ESRD requiring dialysis) will have 2 in-house periods (separated by at least 7 days), and will receive the single doses of AAI101 in combination with cefepime antibiotic once after dialysis and once before dialysis. The follow-up visit for Group 4 will occur on Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on Day 14 (±2 days), counting from Day 1 of the second period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PK in Patients With Various Degrees of Renal Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cefepime/AAI101 combination
Arm Type
Experimental
Arm Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
cefepime/AAI101
Intervention Description
Fixed dose combination of cefepime and AAI101
Primary Outcome Measure Information:
Title
The maximum plasma concentration (Cmax) of cefepime and AAI101
Description
Cmax will be compared before and after administration of a single dose of cefepime/AAI101
Time Frame
Up to 48 hours post-dose
Title
AUC0-inf: area under the concentration-time curve (AUC) from time 0 extrapolated to infinity of cefepime and AAI101
Description
AUC0-inf will be compared before and after administration of a single dose of cefepime/AAI101
Time Frame
Up to 48 hours post-dose
Secondary Outcome Measure Information:
Title
The number of volunteers with adverse events as a measure of safety and tolerability
Description
Assessments will be made via recording of AEs.
Time Frame
Up to 96 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Main Inclusion Criteria
Adult male or female subjects age 18 to 70 years, inclusive
BMI 18.0 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2) Subjects with Renal Impairment (in addition)
Stable renal impairment, defined as no clinically significant change in disease status, as judged by the Investigator Healthy Subjects (in addition)
Subjects with normal renal function as evidenced by CLcr
Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality OR Subject has a stable disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control.
Facility Information:
Facility Name
Pharmaceutical Research Associates CZ, s.r.o.
City
Praha
State/Province
Jankovcova
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
PRA Magyarország Kft Fázis I-es Klinikai Farmakológiai Vizsgálóhely
City
Budapest
State/Province
Rottenbiller Utca 13
ZIP/Postal Code
HJ-1077
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects
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