Group 3: Moderate; Child-Pugh B for Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Liver DiseaseSiremadlin - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Liver Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 0 Secondary · Reporting Duration: 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

Hour 144
Pharmacokinetics (PK): AUC0-24h
Pharmacokinetics (PK): AUC0-t
Pharmacokinetics (PK): AUClast
Pharmacokinetics (PK): CL/F
Pharmacokinetics (PK): Cmax
Pharmacokinetics (PK): T1/2
Pharmacokinetics (PK): Tlast
Pharmacokinetics (PK): Tmax
Pharmacokinetics (PK): Vz/F

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Group 3: Moderate; Child-Pugh B
1 of 4
Group 4: Severe; Child-Pugh C
1 of 4
Group 1: Healthy Control
1 of 4
Group 2: Mild; Child-Pugh A
1 of 4

Experimental Treatment

48 Total Participants · 4 Treatment Groups

Primary Treatment: Group 3: Moderate; Child-Pugh B · No Placebo Group · Phase 1

Group 3: Moderate; Child-Pugh B
Drug
Experimental Group · 1 Intervention: Siremadlin · Intervention Types: Drug
Group 4: Severe; Child-Pugh C
Drug
Experimental Group · 1 Intervention: Siremadlin · Intervention Types: Drug
Group 1: Healthy Control
Drug
Experimental Group · 1 Intervention: Siremadlin · Intervention Types: Drug
Group 2: Mild; Child-Pugh A
Drug
Experimental Group · 1 Intervention: Siremadlin · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,857 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a Child-Pugh score of 7-9, inclusive.
Participants with impaired hepatic function and other stable medical disorders such as diabetes, hypertension, hyperlipidemia, hypothyroidism etc.
You are a non-smoker or moderate smoker (up to 10 cigarettes or equivalent nicotine containing products per day) at Screening
You must weigh at least 50.0 kg and have a BMI within the range of 18.0 to 38.
You must weigh at least 50.0 kg and must have a BMI within the range of 18.0 to 38.0 kg/m2, inclusive at Screening.
You have a Child-Pugh score of 5-6, inclusive.