Study in Participants With Normal Kidney Function and Reduced Kidney Function to Test How Kidney Function Can Change What Happens to Obeldesivir in the Body

Exclusion Criteria34

• Positive serum pregnancy test at screening and at admission. Admission urine pregnancy test can be performed in addition to, but not in place of, admission serum pregnancy test when expedited serum pregnancy test results are unavailable.
• Breastfeeding participant.
• Participants who plan to donate sperm from clinic admission (ie, Day -1) throughout the
• study period, and through the required contraception period.
• Have received any study drug within 30 days prior to study dosing.
• Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or admission.
• Have a positive test result for HIV-1 or HIV-2 antibodies, hepatitis B virus (HBV) surface
• antigen, or hepatitis C virus (HCV) antibody at screening.
• Have poor venous access that limits phlebotomy.
• Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, other immune- or cytokine-based therapies).
• Have any psychiatric illness (including depression) that, in the opinion of the investigator,
• would interfere with participant treatment, assessment, or compliance with the protocol.
• Have a history of any of the following:
• a) Significant serious skin disease, such as but not limited to rash, food allergy, eczema,
• psoriasis, or urticaria.
• b) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatotoxicity).
• c) Known hypersensitivity to the study drug, its metabolites, or to formulation excipients
• d) Significant cardiac disease (including history of myocardial infarction based on ECG
• and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or
• dilated cardiomyopathy with left ventricular ejection fraction less than or equal to 40%); or a family history
• of long QT syndrome, or unexplained death in an otherwise healthy individual between
• the ages of 1 and 30 years.
• e) Syncope, palpitations, or unexplained dizziness.
• f) Implanted defibrillator or pacemaker.
• g) Liver disease, including Gilbert syndrome.
• h) Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid
• hypersecretory conditions requiring prolonged (greater than or equal to 6 months) medical treatment.
• i) Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or
• intestinal surgery). A history of cholecystectomy is not exclusionary.
• Requirement for ongoing therapy with or prior use of any prohibited medications
• Participants with RI requiring or anticipated to require dialysis within 6 months of dosing are not eligible.
• Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to study drug administration, with the exception of vitamins, and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
• Have any serious or active medical illness that, in the opinion of the investigator, would
• interfere with participant treatment, assessment, or compliance with the protocol. This would include cardiac, haematological, hepatic, pulmonary (including chronic asthma), endocrine(including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), and immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.