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

Completed · Phase 1 · Has a placebo group

Conditions studied: Liver Disease

In brief

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

Key facts

Study ID

NCT04408937

Run by

Novartis Pharmaceuticals

People needed

89

Starts

2020-05-29

Expected to finish

2020-11-04

Last updated by the study team

2022-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of Liver Disease

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.