Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- * Females must have a negative pregnancy test at Screening and prior to dosing
- * BMI of 18.5 to 43.0 kg/m2
- * Willing to comply with the study requirements and to provide written informed consent
- * Considered stable in the judgement of an Investigator
- * Presence of severe renal impairment or kidney failure (as defined by eGFR\< 30 mL/ min)
- * Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
- * Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).
- * Medically healthy, in the opinion of an Investigator
- * Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment
- * Pregnant or breastfeeding
- * Infected with hepatitis B virus, hepatitis C virus or HIV
- * Abuse of alcohol or drugs
- * Use of other investigational drugs within 28 days of dosing
- * Other clinically significant medical conditions or laboratory abnormalities
- * Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \> 10%
- * Undergoing any method of dialysis
- * Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan
- * History of renal transplant
- * Concurrent use of medications known to affect the elimination of serum creatinine
- * History of liver transplant
- * Evidence of hepatic carcinoma presence at Screening
Ages Eligible for Study
18 Years to 80 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes