The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.

Liver Disease Clinical Trial

Official title:

A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408937
• Other study ID #: CLJN452A2113
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2020
• Est. completion date: November 4, 2020

Study information

• Verified date: February 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.

Description:

This was a randomized, subject and investigator blinded, multicenter, parallel-arm study to assess the safety and tolerability of tropifexor dosed in the evening as compared to dosing in the morning in subjects with non-alcoholic steatohepatitis (NASH). Subjects whose eligibility was confirmed were randomized with stratification by domicile status at Day 1 of the treatment period into tropifexor (200 μg) AM dose group (hereafter referred to as AM dose group) or tropifexor (200 μg) PM dose group (hereafter referred to as PM dose group) in a 1:1 ratio. Subjects in the AM dose group took tropifexor in the morning and placebo in the evening while subjects in the PM dose group took placebo in the morning and tropifexor in the evening for 4 weeks in a blinded manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Glycated hemoglobin (HbAlc) = 9.5% at screening

-Calculated estimated glomerular filtration rate (eGFR) = 60 mL/min/1.73m2 (using the Modification of diet in renal disease (MDRD) formula) Subjects with contraindications to Magnetic resonance imaging (MRI) imaging.

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Drug:
• triopifexor
Tropifexor as a dry blend in hard gelatin capsules for oral administration
• Placebo
Placebo capsules for oral administration

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Coronado	California
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Hermitage	Tennessee
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Madison	Alabama
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Morehead City	North Carolina
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment		week 2
Secondary	Change in fasting circulating High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels over 4 weeks of treatment		week 4
Secondary	Change in ALT, AST and GGT over 4 weeks of treatment		week 4
Secondary	PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients		week 4
Secondary	PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients		4 weeks

External Links

•   A Plain Language Trial Summary is available on novctrd.com
•   Results for CLJN452A2113 can be found on the Novartis Clinical Trial Results Website.