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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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,315 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for people to still enroll in this clinical experiment?

"As indicated on clinicaltrials.gov, this ongoing medical trial began recruitment on December 2nd 2022 and was recently updated on the 14th of December 2022."

Answered by AI

Has the FDA officially sanctioned Group 3: Moderate; Child-Pugh B?

"Since there is only a limited amount of research backing up its safety and efficacy, Group 3: Moderate; Child-Pugh B was given an assessment score of 1."

Answered by AI

Is the sample pool of this experiment limited to adults aged 65 or younger?

"This medical study has an age requirement of 18 to 75 years old. There are 27 studies for those younger than the mandated minimum and 223 studies available to individuals older than 65."

Answered by AI

Are there any restrictions on who can participate in this trial?

"The requirements for joining this trial are hepatic impairment and an age range between 18 and 75. Our team is seeking to enrol 48 qualified participants in total."

Answered by AI

What is the enrollment cap for this trial?

"Affirmative. The clinicaltrials.gov database shows that this research trial, first advertised on December 2nd 2022, is currently enrolling participants. A total of 48 patients need to be recruited from 3 distinct medical facilities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment
2022. "Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05599932.
~16 spots leftby Apr 2025
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