Clareo Health | A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function
A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–79
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent
Renally Impaired Participants and Disease Characteristics
* Mildly or moderately decreased renal function, as assessed by estimated glomerular filtration rate (eGFR). Mildly impaired renal function: eGFR: 60 up to 89 mL/min/1.73 m\^2 (inclusive); Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m\^2 (inclusive)
* Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening
Participants with normal renal function: Normal renal function, as assessed by eGFR ≥90 mL/min/1.73 m\^2
Body mass index (BMI) within the range 18 - 40 kg/m\^2 (inclusive)
Body weight (bw) ≥ 45 kg
Study participants of reproductive potential must agree to use adequate contraception when sexually active.
Male participants must agree not to donate sperm from the signing of the ICF until the follow-up visit on Day 12 (± 2d).
You may not be if
Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment
Acute renal failure or acute nephritis within the past 2 years
Febrile illness within 1 week before study drug administration
Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
Conditions associated with a risk of hypersensitivity reactions as judged by the investigator
Any participant not able to produce urine and/or needing dialysis
Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention
Contrast agent administration within one month prior to screening or during the screening period
Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention
Clinically relevant abnormalities in physical examination, ECG, clinical chemistry, hematology, or urinalysis as judged by the investigator
Heart rate below 45 bpm or above 110 bpm
Systolic blood pressure below 90 mmHg or above 170 mmHg
Diastolic blood pressure below 45 or above 105 mmHg
Indication or evidence for long QT syndrome for all participants; additionally for participants with normal renal function: QT interval corrected using Fridericia's method (QTcF) \> 470 msec
History of COVID-19 within 6 months prior to screening
Long COVID-19 syndrome or other clinically relevant COVID-19-related symptoms or sequela
Incomplete SARS-CoV-2 vaccination
Vaccination planned before completion of the last study visit
