Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
\- Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m\^2) and body weight of at least 45 kilograms (kg)
Control group participants, Part 1 only:
Normal renal function based on creatinine clearance greater than or equal to (\>=) 90 milliliters per minute (mL/min) at the Screening visit
Healthy for age-group, as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
Participants with renal impairment, Part 1 only:
Reduced renal function based on estimated creatinine clearance at the Screening visit. Creatinine clearance can be estimated from serum creatinine concentration at the Screening visit using the Cockcroft-Gault equation, or be a historical measured value obtained within the preceding 3 months. Participants with severe, moderate or mild renal impairment must have creatinine clearance of less than or equal to (\<=) 29, 30 to 59, or 60 to 89 mL/min, respectively
Stable renal function. The stability of renal function will be confirmed by two determinations of serum creatinine separated by at least 7 days (one of which can be a historical value within the last 3 months). Renal function will be considered stable if the 2 serum creatinine values differ by \<=30 percent (%) of the lower value
Participants with end-stage renal disease in Part 2 only:
Reduced renal function with a clinical diagnosis of end-stage renal disease requiring renal replacement therapy
Receiving hemodialysis for more than 3 months at the time of the Screening visit
You may not be if
Recipient of a renal transplant (Part 1 only)
Presence of renal carcinoma, or acute renal disease caused by infection or drug toxicity
Nephrotic syndrome (defined as plasma albumin less than \[\<\] 3 grams per deciliter \[g/dL\] and/or proteinuria greater than \[\>\] 3 grams per day \[g/day\])
Hemoglobin concentration \<10 g/dL, or \<9 g/dL for participants with end-stage renal disease
Potassium concentration \>5.5 millimoles per liter (mmol/L)
Clinically significant liver disease
Uncontrolled blood pressure
Any condition associated with intra-vascular volume depletion
Any unstable clinically significant disease
Any other ongoing condition or disease (apart from renal dysfunction), or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study
Major surgery or significant traumatic injury \<28 days prior to the first administration (excluding biopsies), or anticipation of the need for major surgery during study treatment
Recent history of alcoholism, drug abuse, or addiction within the last year prior to screening
Positive test at Screening of any of the following: Hepatitis A, Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV)
Clinically significant change in disease status as judged by the investigator, or any major illness within the 4 weeks prior to the Screening visit, or febrile illness within 14 days prior to the Screening visit
Use of prohibited medications, or alteration to a concomitant medication treatment regimen considered relevant by the investigator within 14 days before the Screening visit
Known history of clinically significant hypersensitivity or severe allergic reaction to any drug, in particular antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams)
Participation in another clinical study with an investigational drug or device within the 1 month preceding the Screening vist
Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the Screening visit
Clareo Health | A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901
