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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04408937
Recruitment Status : Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Liver Disease Drug: triopifexor A Drug: tropifexor B Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Investigator and Subject Blinded, Multicenter, Parallel-arm Study to Determine the Safety and Tolerability of Tropifexor.
Estimated Study Start Date : July 13, 2020
Estimated Primary Completion Date : May 12, 2021
Estimated Study Completion Date : May 12, 2021

Arm Intervention/treatment
Experimental: tropifexor A
LJN452/placebo
Drug: triopifexor A
LJN452/placebo

Experimental: tropifexor B
placebo/LJN452
Drug: tropifexor B
placebo/LJN452




Primary Outcome Measures :
  1. Change from baseline in fasting circulating LDL-C levels after 2 weeks of tropifexor treatment [ Time Frame: week 2 ]

Secondary Outcome Measures :
  1. Change in fasting circulating High density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels over 4 weeks of treatment [ Time Frame: week 4 ]
  2. Change in ALT, AST and GGT over 4 weeks of treatment [ Time Frame: week 4 ]
  3. PK parameters include but not limited to Cmax (ng/ml) will be assessed in the domiciled patients [ Time Frame: week 4 ]
  4. PK parameters include but not limited to area under the curve (AUC) will be assessed in the domiciled patients [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 HbAlc ≥ 9.5% at screening

-Calculated eGFR ≤ 60 mL/min/1.73m2 (using the MDRD formula) Subjects with contraindications to MRI imaging.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408937


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04408937    
Other Study ID Numbers: CLJN452A2113
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
tropifexor
FXR agonist
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases