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JDQ443 for Liver Impairment

Phase 1
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must weigh at least 50.0 kg to participate in the study and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Awards & highlights

Study Summary

This trial is testing a new drug to see how well it works in people with different degrees of liver impairment, and to see if it is safe and well tolerated.

Who is the study for?
This trial is for adults who weigh at least 50 kg with a BMI of 18-40. They must understand the study and stay in the clinic as needed. It's not for those using other investigational drugs recently, pregnant or nursing women, people allergic to JDQ443 or its ingredients, or those on certain medications affecting liver enzymes.Check my eligibility
What is being tested?
The study tests how liver function affects the body's handling of JDQ443, a drug under investigation for treating lung cancer. Participants with different levels of liver health are compared to healthy individuals to see differences in drug processing and safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions related to JDQ443 which could include issues with how their body processes the drug due to impaired liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 50 kg and my BMI is between 18 and 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent Total Body Clearance From Plasma (CL/F) of JDQ443 following Drug Administration
Apparent Volume of Distribution of JDQ443 during Terminal Phase (Vz/F)
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of JDQ443
+7 more
Secondary outcome measures
Apparent Total Body Clearance From Plasma (CL/F) of unbound JDQ443
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of unbound JDQ443
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of unbound JDQ443
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Severe hepatic impairmentExperimental Treatment1 Intervention
Severe hepatic impairment with Child Pugh C (score from 10 to 15)
Group II: Normal hepatic functionExperimental Treatment1 Intervention
Matched healthy participants with normal hepatic function
Group III: Moderate hepatic impairmentExperimental Treatment1 Intervention
Moderate hepatic impairment with Child Pugh B (score from 7 to 9)
Group IV: Mild hepatic impairmentExperimental Treatment1 Intervention
Mild hepatic impaired participants with Child-Pugh A (score of 5 to 6)

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
2,856 Previous Clinical Trials
4,197,657 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
2022. "A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05329623.
All > Small Cell Lung Cancer > Sclc
~2 spots leftby Jun 2024
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