Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Hepatic Impairment, sponsored by EMD Serono Research & Development Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The area under the plasma concentration time curve (AUC) from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at the last sampling time (tlast), as estimated using the linear regression from lambda z determination. AUC(0- inf)=AUC0-t plus Clastpred/lambda z where Clastpred was last predicted concentration. Lambda Z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve.
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 |
What the finished NCT03546608 record still lists
NCT03546608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03546608's enrollment target sits among peer trials
18 42nd of 48 higher than 5 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
RECRUITING · Phase 1
-
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
RECRUITING · Phase 1
-
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
RECRUITING · Phase 1
-
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
RECRUITING · Phase 1
-
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
RECRUITING · Phase 1
-
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI