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:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT04226833
Eligibility Criteria:
Inclusion Criteria:
All participants:
* A body mass index (BMI) between 18.0 and 38.0 kg/m2, and weighing at least 50 kg
* Agreement to comply with measures to prevent pregnancy and restrictions on sperm donation.
Participants with normal hepatic function:
* Normal hepatic function and no history of clinically significant hepatic dysfunction.
* Healthy for age-group in the opinion of the Investigator.
Participants with hepatic impairment:
* Mild, moderate or severe hepatic dysfunction (i.e. Child-Pugh A, B or C, NCIODWG Mild, Moderate or Severe) arising from cirrhosis of the liver as the result of parenchymal liver disease.
* Stable hepatic function.
Exclusion Criteria:
* Transjugular intrahepatic portosystemic shunt or other porta-caval shunt.
* A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers.
* Recent history or signs of severe hepatic encephalopathy (e.g., a portal systemic encephalopathy score \>2).
* Advanced ascites or ascites which require emptying and albumin supplementation.
* Hepatocellular carcinoma, acute liver disease or serum ALT or AST not consistent with stable disease.
* Recipient of a liver transplant.
* Uncontrolled hypertension.
* Clinically significant impairment of renal function.
* A history of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract.
* Clinically significant change in health status, or any major illness, or clinically significant acute infection or febrile illness.
* Women who are pregnant or lactating.
* Presence of any abnormal ECG finding, which is clinically significant.
* Use of moderate or potent inhibitors or inducers of cytochrome P450 3A4 enzyme.
* Participation in any other clinical study involving administration of an investigational medicinal product or use of an unapproved device.
* A positive test result for human immunodeficiency virus (HIV).
* Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds or other excipients in the entrectinib formulation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04226833
Study Brief:
Protocol Section:
NCT04226833