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.

Condition

Liver Disease

Phase

Phase 1

Overall status

Recruiting

Enrollment count

80 participants

Start date

May 29, 2020

Completion date

Mar 31, 2021

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

triopifexor A

LJN452/placebo

Drug

tropifexor B

placebo/LJN452

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.