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

Inclusion criteria

• 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).

Exclusion criteria

• 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