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

NCT ID: NCT05329623

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2024-04-07

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 impairment.

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 matched healthy control participants.

The study comprises a 28-day Screening period (Days -28 to -2), a baseline evaluation period (Day -1), a single dose administration of 200 mg of JDQ443 (Day 1), and a follow-up period of 4 days (Days 2 to 4) for PK sample collection. All participants should have a post-study safety follow-up contact conducted approximately 30 days after last administration of study treatment. The study will be considered complete once all the participants have finished the required assessments or have dropped out or been lost to follow-up.

A total of up to 48 participants will be enrolled in this study. Approximately 8 participants will be enrolled in each of mild (Child-Pugh A; Group 2), moderate (Child-Pugh B; Group 3), and severe (Child-Pugh C; Group 4) hepatic impairment groups (to have at least six evaluable participants in each group). Each participant in the healthy control group (Group 1) will be matched to one or more evaluable participants with hepatic impairment with respect to age, body weight and sex. All participants will receive a single JDQ443 dose. Upon completion of mild and moderate impairment groups, as well as matching control participants, an interim analysis will be conducted to compare the PK exposure of the two hepatic impaired groups (Groups 2 and 3) to that of the control participants. The interim analysis is to mitigate the potential safety risks in participants with severe hepatic impairment. If the interim analysis results do not show a clinically relevant increase in exposure of JDQ443 and is well tolerated from a safety perspective, then severe hepatic impairment participants may be enrolled. Participants with severe hepatic impairment will be enrolled only after the completion of the interim analysis.

Conditions

Small Cell Lung Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal hepatic function

Matched healthy participants with normal hepatic function

Group Type: EXPERIMENTAL

JDQ443

Intervention Type: DRUG

All the participants will receive a single oral dose of JDQ443.

Mild hepatic impairment

Mild hepatic impaired participants with Child-Pugh A (score of 5 to 6)

Group Type: EXPERIMENTAL

JDQ443

Intervention Type: DRUG

All the participants will receive a single oral dose of JDQ443.

Moderate hepatic impairment

Moderate hepatic impairment with Child Pugh B (score from 7 to 9)

Group Type: EXPERIMENTAL

JDQ443

Intervention Type: DRUG

All the participants will receive a single oral dose of JDQ443.

Severe hepatic impairment

Severe hepatic impairment with Child Pugh C (score from 10 to 15)

Group Type: EXPERIMENTAL

JDQ443

Intervention Type: DRUG

All the participants will receive a single oral dose of JDQ443.

Interventions

JDQ443

All the participants will receive a single oral dose of JDQ443.

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Texas Liver Institute

San Antonio, Texas, United States

Countries

United States

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18281

Link to study results

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2550

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

CJDQ443B12103

Identifier Type: -

Identifier Source: org_study_id