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Clinical Trial Details

Trial ID: L0823
Source ID: NCT04699656
Associated Drug: Plazomicin Injection
Title: Plazomicin Study in ESRD Patients Receiving IHD
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: Plazomicin Injection
Outcome Measures: Primary: o Maximum observed plasma drug concentration (Cmax), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Time to maximum observed plasma concentration (Tmax), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Area under the plasma concentration time curve from time 0 to the last measurable concentration (AUC0-t), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Area under the plasma concentration time curve extrapolated to infinity (AUCinf), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Terminal elimination half-life (t1/2), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Total plasma clearance (CL), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Volume of distribution during the terminal elimination phase (Vz), Plasma PK parameter for plazomicin before and after IHD, 30 days|o Terminal elimination rate constant (λz), Plasma PK parameter for plazomicin before and after IHD, 30 days | Secondary: • Adverse events (AEs), Safety assessment; An overall summary will be generated presenting the frequency and percentage of subjects and the number of treatment-emergent adverse events (TEAEs)., 30 days | Other: o Cumulative amount of drug excreted in dialysate (Ae), Dialysate PK parameter for plazomicin after IHD, 30 days|o Percent of plazomicin recovered in dialysate (Ae%), Dialysate PK parameter for plazomicin after IHD, 30 days|o Dialysate clearance (CLD), Dialysate PK parameter for plazomicin after IHD, 30 days
Sponsor/Collaborators: Sponsor: Cipla USA Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 6
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-05
Completion Date: 2021-06-09
Results First Posted:
Last Update Posted: 2022-03-09
Locations: Orlando Clinical Research Center, Orlando, Florida, 32809, United States
URL: https://clinicaltrials.gov/show/NCT04699656