Lung Cancer Trials Ask AI to find trials
CompletedPhase 1NCT05329623
Official study title

A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants.

Study 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 impairment.

Ask AI to explain this study
Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedJDQ443

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: JDQ443
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Orlando Clinical Research CenterOrlando, Florida
  • Texas Liver InstituteSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 10, 2025. Always confirm current availability with the study team.

View original record ↗