Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT04699656
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2020-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plazomicin Study in ESRD Patients Receiving IHD
Sponsor:
Cipla USA Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Administration of Plazomicin in Subjects With End Stage Renal Disease (ESRD) Receiving Intermittent Hemodialysis (IHD)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.
Detailed Description:
This is a Phase 1, single-center, open-label, single-dose study to evaluate the PK of a single dose of plazomicin (30-minute IV infusion at 2.5 mg/kg) when administered prior to and after IHD in subjects with ESRD.
The study will consist of a screening period of up to 28 days and two treatment periods, with at least a 7-day washout between dosing in each treatment period. The start of the study is defined as the date that the first subject is screened following signing of an informed consent form (ICF).
In Period 1 (Week 1), the dosing day will be concomitant with the 3rd weekly IHD session, which must be at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) within 1 hour after IHD is completed. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
In Period 2 (Week 2), the dosing day will occur on the day of the 3rd weekly IHD session, which must be at least 7 days after the first dose and at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) before IHD is started. The plazomicin infusion should be completed within 30 minutes of IHD initiation. During IHD, the total dialysate will be collected in a large collection container and pooled at 1-hour intervals (0-1, 1-2, 2-3, etc. for the duration of the IHD session). From each hourly interval (including any partial interval at end of dialysis), an aliquot sample of dialysate will be collected for PK analysis. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
Safety assessments will include physical examination findings, vital signs (blood pressure, pulse rate, respiration rate, and oral temperature), clinical laboratory evaluations, and monitoring of adverse events (AEs). Adverse events will be assessed from the time the subject signs the ICF until exit from the study.
The site will attempt to contact all subjects (including subjects who terminate the study early) via phone call approximately 14 days after the last dose of study drug to determine if any AE has occurred since the last study visit. Subjects reporting AEs may be asked to return to the site for further assessment.
The study will consist of a screening period of up to 28 days and two treatment periods, with at least a 7-day washout between dosing in each treatment period. The start of the study is defined as the date that the first subject is screened following signing of an informed consent form (ICF).
In Period 1 (Week 1), the dosing day will be concomitant with the 3rd weekly IHD session, which must be at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) within 1 hour after IHD is completed. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
In Period 2 (Week 2), the dosing day will occur on the day of the 3rd weekly IHD session, which must be at least 7 days after the first dose and at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) before IHD is started. The plazomicin infusion should be completed within 30 minutes of IHD initiation. During IHD, the total dialysate will be collected in a large collection container and pooled at 1-hour intervals (0-1, 1-2, 2-3, etc. for the duration of the IHD session). From each hourly interval (including any partial interval at end of dialysis), an aliquot sample of dialysate will be collected for PK analysis. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
Safety assessments will include physical examination findings, vital signs (blood pressure, pulse rate, respiration rate, and oral temperature), clinical laboratory evaluations, and monitoring of adverse events (AEs). Adverse events will be assessed from the time the subject signs the ICF until exit from the study.
The site will attempt to contact all subjects (including subjects who terminate the study early) via phone call approximately 14 days after the last dose of study drug to determine if any AE has occurred since the last study visit. Subjects reporting AEs may be asked to return to the site for further assessment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: