A single injection dose study of DUR-928 in patients with impaired kidney function and healthy volunteers

Phase 1

Completed

• Conditions: Impaired Kidney Function – stage 3 and 4; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12616000389404
• Lead Sponsor: George Clinical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

All participants:
Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed
Female subjects must be of non-childbearing potential
Willing and be able to be admitted to the clinical study unit for 3 nights and 3 days
Able to abstain from alcohol and tobacco use during the study
Patient with impaired kidney function:
Impaired kidney function at screening, defined as Stage 3 kidney disease (eGFR between 30 and 59 ml/min/1.73m2) and stage 4 kidney disease (eGFR between 15 and 29 ml/min/1.73m2)
Existing diagnosis of chronic kidney disease
Matching healthy control subjects:
Healthy as determined by medical history, physical examination, laboratory tests, ECG and vital signs in consideration of the individual’s age

Exclusion Criteria

All participants:
Females of child-bearing potential; pregnant or breastfeeding
Significant blood loss, donated blood or received medication in another clinical trial 30 days prior to study participation
Be immunocompromised (including history/seropositive of HIV)
Be receiving any pharmacological treatment which might alter the absorption or metabolism of drugs
Have a history of febrile illness 5 days prior to dosing
Positive drug of abuse or alcohol breath test
History of malignancy within 5 years before screening (except squamous and basal cell carcinomas of the skin and carcinomas of the cervix in situ, or a malignancy that in the opinion of the study physician and the medical monitor as cured with minimal risk of recurrence
History of maintenance dialysis or kidney transplant
History or presence of clinically concerning arrhythmias or prolongation of screening QT or QTc intervals
Patient with impaired kidney disease:
History of clinically significant comorbidity that increases the risk of adverse events
Have any surgical or medical condition (other than impaired kidney disease) which might significantly alter the absorption or metabolism of drugs or which may jeopardies the subject during participation
Presence of impaired liver function
Clinical evidence of active liver disease, liver cirrhosis or severe ascites requiring intervention
Symptoms or history of hepatic encephalopathy within 4 weeks of study entry
Evidence of progressive kidney disease or unstable kidney function in the view of the investigator
Matching healthy control subjects:
Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic disease (excluding well treated, asymptomatic seasonal allergies)
Have any surgical or medical condition which might significantly alter the absorption or metabolism of drugs or which may jeopardies the subject during participation
Presence of impaired liver function
Clinical evidence of kidney disease or kidney injury

Study & Design

• Study Type: Interventional
• Study Design: Not specified