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

Korábbi kezelés

• 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.

Más betegség

• Contradiction or hypersensitivity to the investigational compound/compound class or its excipients being used in this study.

Laborértékek

• 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

• 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.