NCT04408937

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Liver Disease

Interventions

Type	Name	Description
DRUG	triopifexor	Tropifexor as a dry blend in hard gelatin capsules for oral administration
DRUG	Placebo	Placebo capsules for oral administration

Timeline

• Start date: 2020-05-29
• Primary completion: 2020-11-04
• Completion: 2020-11-04
• First posted: 2020-05-29
• Last updated: 2022-02-09

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study