Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03681457 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03681457 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 42 participants.
The verdict
NCT03681457, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.
Interventions
- DRUG LJN452
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2019-09-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03681457
The ClinicalTrials.gov registry entry for NCT03681457 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LJN452 is the first listed.
NCT03681457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03681457 about?
NCT03681457 is a clinical study titled "Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects". The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degre...
What is the current status of trial NCT03681457?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2018-09-24. Estimated completion is 2019-09-25.
What interventions are being tested in trial NCT03681457?
The interventions under investigation include: LJN452 (DRUG).
Who is sponsoring clinical trial NCT03681457?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.