Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Hepatic Impairment, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum Observed Blood Concentrations (Cmax) for siremadlin. Blood samples will be collected to measure Cmax at indicated timepoints. Pharmacokinetic (PK) parameters will be calculated based on siremadlin blood concentrations.
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 |
What the finished NCT05599932 record still lists
NCT05599932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, roughly in line with the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target.
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 a single indexed study location in 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.
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 NCT05599932's enrollment target sits among peer trials
38 10th of 48 higher than 38 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
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
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