Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects

Phase 1

Completed

• Conditions: PK in Patients With Various Degrees of Renal Impairment
• Interventions: Drug: cefepime/AAI101

• Registration Number: NCT03680352
• Lead Sponsor: Allecra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
cefepime/AAI101 combination	cefepime/AAI101	Investigational drug

Primary Outcome Measures

Name	Time	Method
AUC0-inf: area under the concentration-time curve (AUC) from time 0 extrapolated to infinity of cefepime and AAI101	Up to 48 hours post-dose	AUC0-inf will be compared before and after administration of a single dose of cefepime/AAI101
The maximum plasma concentration (Cmax) of cefepime and AAI101	Up to 48 hours post-dose	Cmax will be compared before and after administration of a single dose of cefepime/AAI101

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	Up to 96 hours post-dose	Assessments will be made via recording of AEs.

Trial Locations

Locations (2)

Pharmaceutical Research Associates CZ, s.r.o.; 🇨🇿 Praha, Jankovcova, Czechia

PRA Magyarország Kft Fázis I-es Klinikai Farmakológiai Vizsgálóhely; 🇭🇺 Budapest, Rottenbiller Utca 13, Hungary