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Small Molecule

Group 2: Mild; Child-Pugh A for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, and 144 hours
Awards & highlights

Study Summary

This trial studies how different levels of liver issues affect how well a medicine is absorbed, and how safe and well tolerated it is.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, and 144 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5 hours, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, and 144 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK): AUC0-24h
Pharmacokinetics (PK): AUC0-t
Pharmacokinetics (PK): AUCinf
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4: Severe; Child-Pugh CExperimental Treatment1 Intervention
Each participant with severe Child-Pugh will receive a single dose of HDM201
Group II: Group 3: Moderate; Child-Pugh BExperimental Treatment1 Intervention
Each participant with moderate Child-Pugh will receive a single dose of HDM201
Group III: Group 2: Mild; Child-Pugh AExperimental Treatment1 Intervention
Each participant with mild Child-Pugh will receive a single dose of HDM201
Group IV: Group 1: Healthy ControlExperimental Treatment1 Intervention
Each healthy participant will receive a single dose of HDM201
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Siremadlin
2022
Completed Phase 1
~40

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,868 Previous Clinical Trials
4,199,838 Total Patients Enrolled

Media Library

Siremadlin (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05599932 — Phase 1
Liver Disease Research Study Groups: Group 2: Mild; Child-Pugh A, Group 1: Healthy Control, Group 3: Moderate; Child-Pugh B, Group 4: Severe; Child-Pugh C
Liver Disease Clinical Trial 2023: Siremadlin Highlights & Side Effects. Trial Name: NCT05599932 — Phase 1
Siremadlin (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599932 — Phase 1
~16 spots leftby May 2025
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