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NCT05599932 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 3
- Study locations
NCT05599932 is a Phase 1 study of Hepatic Impairment that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 38 participants, roughly in line with the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target. The trial reports 3 study locations across 2 states.
The verdict
NCT05599932, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 3
- Study locations
Study Summary
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose. In addition, safety and tolerability of siremadlin after a single oral dose will be evaluated. The results of this study will inform the decision whether a dose adjustment may be recommended when treating patients with various degrees of impaired hepatic function.
Conditions Studied
Interventions
- DRUG Siremadlin
Study Locations (3)
Florida
- Clinical Pharmacology of Miami LLC - Miami
- Orlando Clinical Research Center - Orlando
Texas
- Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2022-12-02 |
| Est. Completion | 2023-09-18 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05599932
The ClinicalTrials.gov registry entry for NCT05599932 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 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 Siremadlin is the first listed.
NCT05599932 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05599932 about?
NCT05599932 is a clinical study titled "Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment". The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose. In addition, safety and tolerability of siremadlin after a single oral dose will be evaluated. The results ...
What is the current status of trial NCT05599932?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2022-12-02. Estimated completion is 2023-09-18.
What conditions does trial NCT05599932 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT05599932?
The interventions under investigation include: Siremadlin (DRUG).
Who is sponsoring clinical trial NCT05599932?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05599932 being conducted?
This trial has 3 study locations across Florida, Texas. 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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