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

• Status: Not yet recruiting
• Trial end date: 2023-09-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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