Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03681457
Eligibility Criteria:
All subjects:
Inclusions Criteria:
* Subjects must weight at least 50 kg, with a BMI within the range of 18 to 38 kg/m2
* Must be willing to remain in the clinical research unit as required by the protocol
Exclusion Criteria:
* Use of other study drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
* History of hypersensitivity to the study treatment or to drugs of similar chemical classes
* Pregnant or nursing women
* Women of child-bearing potential
Healthy Volunteers:
Inclusion Criteria:
\- In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.
Exclusion Criteria:
* Liver disease or liver injury
* Chronic infection with Hepatitis B or Hepatitis C
* History or presence of impaired renal function
Hepatically Impaired Subjects:
Inclusion Criteria:
\- Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease
Exclusion Criteria:
* Severe complications of liver disease within the preceding 3 months
* Emergency room visit or hospitalization due to liver disease within the preceding 3 months for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects
* Subject has received liver transplant at any time in the past and is on immunosuppressant therapy
* Acute Hepatitis B or Hepatitis C infection
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03681457
Study Brief:
Protocol Section:
NCT03681457