Eligibility Details:
Inclusion Criteria:
- Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade
3 (for participants with severe hepatic impairment) where the participant lacks the
capacity to provide informed consent as judged by the investigator. Mild or moderate
hepatic encephalopathy that would not impede informed consent in the investigator's
judgment is permitted
- Participants with normal hepatic function must be in good health with no clinically
significant findings from medical history, physical examination, vital signs, and
laboratory evaluation, unless deemed not clinically significant by the investigator
- Participants with normal hepatic function must have serum creatinine within normal
limits and Creatinine Clearance (CrCL) greater than (>) 60 milliliter per minute per
1.73 meter square (mL/min/1.73 m^2) as calculated per Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) Creatinine Equation
- Participants with severe hepatic impairment must have a total Child-Pugh score of 10
to 15 inclusive, as determined by the investigator during screening and on Day -1
prior to study drug administration. Source documents to substantiate the clinical
diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory
results or clinical findings), and medical history will be reviewed and signed by the
investigator
- Participants with severe hepatic impairment must have CrCL) >= 45 mL/min/1.73 m^2 as
calculated per CKD-EPI Creatinine Equation
Exclusion Criteria:
- Any participant with screening thyroid stimulating hormone (TSH) level > upper limit
of normal (ULN)
- Participants with normal hepatic function with presence of sexual dysfunction
(abnormal libido, erectile dysfunction, etc.) or any medical condition that would
affect sexual function
- Participants with normal hepatic function who have Hepatitis A immunoglobulin M
positivity, Hepatitis B surface antigen (HBsAg) positivity, positive serology for
Hepatitis B or Hepatitis C antibodies. Hepatitis B surface antibody positivity is not
exclusionary if participant can provide evidence of Hepatitis B vaccination
- Participants with severe hepatic impairment who have acute or exacerbating hepatitis,
fluctuating or rapidly deteriorating hepatic function as indicated by widely varying
or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment
of either the investigator or the sponsor's medical monitor
- Participants with severe hepatic impairment previously diagnosed with hepatocellular
carcinoma
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
