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NCT03546608 · ClinicalTrials.gov registry record · Phase 1
Tepotinib Hepatic Impairment Trial
A Phase 1 study of Hepatic Impairment, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT03546608 is a Phase 1 study of Hepatic Impairment that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 18 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03546608, a Phase 1 study of Hepatic Impairment, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study Summary
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
Conditions Studied
Interventions
- DRUG Tepotinib
Study Locations (2)
Florida
- Qps Mra, Llc - Miami
- Orlando Clinical Research Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-06-13 |
| Est. Completion | 2019-02-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03546608
The ClinicalTrials.gov registry entry for NCT03546608 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (50% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Tepotinib is the first listed.
NCT03546608 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03546608 about?
NCT03546608 is a clinical study titled "Tepotinib Hepatic Impairment Trial". The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
What is the current status of trial NCT03546608?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-06-13. Estimated completion is 2019-02-05.
What conditions does trial NCT03546608 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT03546608?
The interventions under investigation include: Tepotinib (DRUG).
Who is sponsoring clinical trial NCT03546608?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03546608 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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