The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.
A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.
ClinicalTrials.gov Identifier: NCT04408937
Novartis Reference Number: CLJN452A2113
Last Update: Aug 12, 2020
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.
Interventions
Eligibility Criteria
Inclusion Criteria:
-Presence of Liver Disease
Exclusion Criteria:
Use of other investigational 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.
Subjects taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 3 months before randomization:
Type 1 diabetes and Uncontrolled Type 2 diabetes defined as HbAlc ≥ 9.5% at screening
-Calculated eGFR ≤ 60 mL/min/1.73m2 (using the MDRD formula) Subjects with contraindications to MRI imaging.
Study Locations
Contacts
Have a question?
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