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

NCT04408937 | Completed Phase 1 FDA Drug

• 1 other identifier: CLJN452A2113
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Liver Disease

Keywords

tropifexor; FXR agonist

Outcome Measures

Primary Outcomes (1)

• Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment

  week 2

Secondary Outcomes (4)

• 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

• Change in ALT, AST and GGT over 4 weeks of treatment

  week 4

• PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients

  week 4

• PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients

  4 weeks

Study Arms (2)

tropifexor AM 200 micrograms and Placebo (PM)

EXPERIMENTAL

Tropifexor 200 μg (AM) and Placebo (PM) once daily each

Drug: triopifexor; Drug: Placebo

tropifexor PM 200 micrograms and Placebo (AM)

EXPERIMENTAL

Tropifexor 200 μg (PM) and Placebo (AM) once daily each

Drug: triopifexor; Drug: Placebo

Interventions

triopifexor DRUG

Tropifexor as a dry blend in hard gelatin capsules for oral administration

Also known as: LJN452

tropifexor AM 200 micrograms and Placebo (PM); tropifexor PM 200 micrograms and Placebo (AM)

Placebo DRUG

Placebo capsules for oral administration

tropifexor AM 200 micrograms and Placebo (PM); tropifexor PM 200 micrograms and Placebo (AM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Madison, Alabama, 35758, United States

Location

Novartis Investigative Site

Coronado, California, 92118, United States

Location

Novartis Investigative Site

Miami, Florida, 33014-3616, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32503, United States

Location

Novartis Investigative Site

South Bend, Indiana, 46635, United States

Location

Novartis Investigative Site

Morehead City, North Carolina, 28557, United States

Location

Novartis Investigative Site

Hermitage, Tennessee, 37076, United States

Location

Novartis Investigative Site

Knoxville, Tennessee, 37920, United States

Location

Novartis Investigative Site

Dallas, Texas, 75208-2312, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78215, United States

Location

Related Links

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

MeSH Terms

Conditions

Liver Diseases

Interventions

tropifexor

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: May 29, 2020
• Study Start: May 29, 2020
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)