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

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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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Madison, 35758
Alabama
United States
Novartis Investigative Site
Recruiting
Coronado, 92118
California
United States
Novartis Investigative Site
Recruiting
San Diego, 91942
California
United States
Novartis Investigative Site
Recruiting
Miami, 33014-3616
Florida
United States
Novartis Investigative Site
Recruiting
Pensacola, 32503
Florida
United States
Novartis Investigative Site
Recruiting
South Bend, 46635
Indiana
United States
Novartis Investigative Site
Recruiting
Morehead City, 28557
North Carolina
United States
Novartis Investigative Site
Recruiting
Hermitage, 37076
Tennessee
United States
Novartis Investigative Site
Recruiting
Knoxville, 37920
Tennessee
United States
Novartis Investigative Site
Recruiting
Dallas, 75208-2312
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78215
Texas
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]