Status:
COMPLETED
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics (PK), safety, and tolerability of JDQ443 in participants with varying degrees of hepatic impa...
Detailed Description
This is a Phase 1, open-label, single-dose, multi-center, parallel group study to evaluate the PK of oral JDQ443 in participants with mild, moderate, and/or severe hepatic impairment compared to match...
Eligibility Criteria
Inclusion
- Key inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- 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.
- Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
- Participant must be willing to remain in the clinical research unit as required by the protocol.
- Key exclusion Criteria:
- Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever is longer.
- Use of drugs (prescription, non-prescription and herbal remedies such as St John's wort) known to affect cytochrome p (CYP)3A, including both strong and moderate inhibitors and inducers, within 2 weeks prior to dosing until completion of the EOS Visit.
- Contradiction or hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
- Pregnant or nursing (lactating) women. Pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- Known history of, or current clinically significant arrhythmias, history of prolonged QT correction formula (QTcF) interval or QTcF \>480 msec
- Other inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05329623
Start Date
May 3 2022
End Date
April 7 2024
Last Update
October 10 2025
Active Locations (2)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
2
Texas Liver Institute
San Antonio, Texas, United States, 78215