PK in Patients With Various Degrees of Renal Impairment Clinical Trial
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
| Verified date | June 2022 |
| Source | Allecra |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | December 30, 2018 |
| Est. primary completion date | December 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Pharmaceutical Research Associates CZ, s.r.o. | Praha | Jankovcova |
| Hungary | PRA Magyarország Kft Fázis I-es Klinikai Farmakológiai Vizsgálóhely | Budapest | Rottenbiller Utca 13 |
| Lead Sponsor | Collaborator |
|---|---|
| Allecra |
Czechia, Hungary,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The maximum plasma concentration (Cmax) of cefepime and AAI101 | Cmax will be compared before and after administration of a single dose of cefepime/AAI101 | Up to 48 hours post-dose | |
| Primary | 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 | Up to 48 hours post-dose | |
| Secondary | The number of volunteers with adverse events as a measure of safety and tolerability | Assessments will be made via recording of AEs. | Up to 96 hours post-dose |