NCT05329623CompletedPhase 1
A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.
A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Matched Healthy Control Participants.
Source: ClinicalTrials.gov · Last updated 10 Oct 2025
Brief summary (registry, in English)
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 impairment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 29 Mar 2022
- Start date
- 3 May 2022
- Primary completion date
- 7 Apr 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT05329623
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 33
- From 3 May 2022 to the primary completion date, 7 Apr 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Contradiction or hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
Lab values
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Orlando Clinical Research Center Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Texas Liver Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.