Plazomicin Study in ESRD Patients Receiving IHD

NCT04699656 | Completed Phase 1 FDA Drug

• 1 other identifier: CPH-002-CL-013
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• • Adverse events (AEs)

  30 days

Other Outcomes (3)

• o Cumulative amount of drug excreted in dialysate (Ae)

  30 days

• o Percent of plazomicin recovered in dialysate (Ae%)

  30 days

• o Dialysate clearance (CLD)

  30 days

Study Arms (1)

Plazomicin Injection

EXPERIMENTAL

plazomicin (30-minute IV infusion at 2.5 mg/kg) single dose given before IHD and single dose given after IHD

Drug: Plazomicin Injection

Interventions

Plazomicin Injection DRUG

single dose of plazomicin

Also known as: Zemdri

Plazomicin Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between 18 and 75 years of age with a BMI ≥19 to ≤42 kg/m2 and weight of ≥40 kg
• Pre-existing ESRD requiring in-center IHD for a minimum of 3 months on a schedule of three IHD sessions per week with the third weekly IHD session occurring at least 72 hours before the first weekly IHD session of the subsequent week (e.g. Monday/Wednesday/Friday or Tuesday/Thursday/Saturday)
• Females of childbearing potential must not be breast-feeding, must have a negative serum pregnancy test at screening, and must use a highly effective method of contraception (includes hormonal implants, intrauterine devices, injectable hormones, oral hormonal contraceptives, prior hysterectomy, prior bilateral oophorectomy, or a vasectomized partner whose vasectomy was performed 4 months or more prior to dosing on Day 1) or be abstinent from sexual activity for at least 1 month prior to dosing on Day 1, during the study and through 30 days following the last dose of study drug. Females of non-childbearing potential, defined as women who have not had a period for 12 consecutive months prior to dosing on Day 1, may be enrolled.
• Willing to comply with all study activities and procedures and have provided written informed consent prior to any study procedures and have signed and dated a Health Insurance Portability and Accountability Act (HIPAA) authorization form.

You may not qualify if:

• Subjects with any medical, psychological, or social condition which, in the opinion of the Investigator, would prevent the subject from fully participating in the study, would represent a concern for study compliance or would constitute a safety concern to the subject.
• Unstable cardiovascular disease per the Investigator, including:
• Heart rate \<40 or \>110 beats per minute (bpm) or QT interval corrected using Fridericia's formula (QTcF) \>500 msec.
• Uncontrolled hypertension, asthma, diabetes (type I or type II), thyroid disease, or seizure disorder
• Myasthenia gravis or any other neuromuscular disorder.
• Known infection with hepatitis B (antigen positive), hepatitis C (antibody positive), or human immunodeficiency virus (HIV). Subjects with clinically insignificant or adequately treated hepatitis C may be allowed at the discretion of the Investigator.
• Active malignancy; carcinoma in situ of the prostate or cervix or basal cell or squamous cell carcinoma of the skin are permitted.
• Presence of functioning transplant organ or blood procedure.
• Significant change in either over-the-counter or prescription medications or supplements within 3 months prior to dosing, defined as any new medication or any dosage adjustment that is significant in the judgment of the Investigator.
• History of significant hearing loss or a family history of hearing loss, excluding age-related (≥65 years) hearing loss. A prior diagnosis of sensorineural hearing loss or Ménière's disease or receipt of any potentially ototoxic agent within 30 prior to the start of screening.
• Subjects who received a systemic aminoglycoside within 90 days of the start of screening.
• Clinically significant illness, including viral syndromes within three weeks of dosing.
• Current participation in a clinical study of an investigational product.
• Subjects who took any investigational medication/therapy within 30 days or 5 half-lives, whichever is longer, before dosing of plazomicin.
• Subjects with active alcoholism and/or drug/chemical abuse in the opinion of the Investigator. Also, consumption of any amount of ethanol within 48 hours of plazomicin dosing.

Sponsors & Collaborators

• Cipla USA Inc.: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

plazomicin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrice P Rioux, MD, PhD

  Cipla USA Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 7, 2021
• Study Start: January 5, 2021
• Primary Completion: March 8, 2021
• Study Completion: June 9, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

US (1)