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Clinical trial

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.

ID
Name
CJDQ443B12103
Description
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.
Trial arms
Trial start
2022-05-03
Estimated PCD
2024-06-17
Trial end
2024-06-17
Status
Recruiting
Phase
Early phase I
Treatment
JDQ443
All the participants will receive a single oral dose of JDQ443.
Arms:
Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function, Severe hepatic impairment
Size
48
Primary endpoint
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Time to Reach the Maximum Concentration of JDQ443 After Drug Administration (Tmax) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Time of observation prior to the first observation with a measurable concentration (Tlag) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Terminal Elimination Half-life (T1/2) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Apparent Total Body Clearance From Plasma (CL/F) of JDQ443 following Drug Administration
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Apparent Volume of Distribution of JDQ443 during Terminal Phase (Vz/F)
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Area Under the Plasma Concentration-time Curve from Time Zero to time "t" (AUC0-t) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Latest pharmacokinetic sampling time with a measurable concentration (Tlast) of JDQ443
Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3 , 4 , 6 , 8 , 12 , 24 , 36 , 48 and 72 hours post-dose
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2024-03-01

1 organization

1 product

1 indication

Organization
Novartis Pharmaceuticals
Product
JDQ443
Indication
Small Cell Lung Carcinoma