Status:
COMPLETED
The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- Presence of Liver Disease
Exclusion
- 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.
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04408937
Start Date
May 29 2020
End Date
November 4 2020
Last Update
February 9 2022
Active Locations (10)
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1
Novartis Investigative Site
Madison, Alabama, United States, 35758
2
Novartis Investigative Site
Coronado, California, United States, 92118
3
Novartis Investigative Site
Miami, Florida, United States, 33014-3616
4
Novartis Investigative Site
Pensacola, Florida, United States, 32503