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NCT02474537 · ClinicalTrials.gov registry record · Phase 1
INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02474537 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants.
The verdict
NCT02474537, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This is a phase I, multi-center, open-label, single oral dose, parallel group study to evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired hepatic function and non-cancer subjects with normal hepatic function.The study population will be healthy male and postmenopausal or sterile female subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will be assigned to groups according to their hepatic function: normal (Group 1), mild (Group 2), moderate (Group 3), and severe (Group 4) impairment. This study consists of a two-staged design with interim analysis. In Stage 1, subjects in Groups 1, 2 and 3 will be enrolled. Upon completion of Stage 1, an interim analysis will be conducted. Depending on the results of the analysis, either the study will conclude with no further enrollment or Stage 2 will commence with enrollment of Group 4. A minimum of 6 evaluable subjects per group will be enrolled.Once enrolled in the study, participants will be confined to the facility for 4 days, given a single dose of INC280 and monitored for pharmacokinetic and safety assessments.
Interventions
- DRUG INC280
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2015-06-12 |
| Est. Completion | 2017-09-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02474537
The ClinicalTrials.gov registry entry for NCT02474537 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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 INC280 is the first listed.
NCT02474537 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02474537 about?
NCT02474537 is a clinical study titled "INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function". This is a phase I, multi-center, open-label, single oral dose, parallel group study to evaluate the pharmacokinetics and safety of INC280 in non-cancer subjects with impaired hepatic function and non-cancer subjects with normal hepatic function.The study population will be healthy male and postmenop...
What is the current status of trial NCT02474537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2015-06-12. Estimated completion is 2017-09-12.
What interventions are being tested in trial NCT02474537?
The interventions under investigation include: INC280 (DRUG).
Who is sponsoring clinical trial NCT02474537?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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