- Has history of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment [Child-Pugh Score {>=} 7]) or renal insufficiency (severe renal impairment [estimated creatinine clearance below 30 {milliliter per minute} mL/min]; serum creatinine >2 [milligram per deciliter] mg/dL); significant and/or unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the participant's condition or affect the participant's safety during the study (eg, medically frail participant with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary