Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants
A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Pharmacokinetic parameters of pelacarsen: Cmax
Time frame: Day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), Day 2, Day 3, Day 4, Day 8, Day 30 and Day 60
Pharmacokinetic parameters of pelacarsen: AUClast
Time frame: Day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), Day 2, Day 3, Day 4, Day 8, Day 30 and Day 60
Pharmacokinetic parameters of pelacarsen: AUCinf
Time frame: Day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), Day 2, Day 3, Day 4, Day 8, Day 30 and Day 60
Eligibility Criteria
Inclusion Criteria: All participants 1. Signed informed consent must be obtained prior to participation in the study. 2. Male and non-child bearing potential female participants, 18 to 75 years of age (inclusive), at Screening. 3. Participants must weigh at least 50 kg to participate in the study, and must have a BMI within the range of 18.0 - 38.0 kg/m2, at Screening. 4. Ability to communicate well with the investigator, to understand and comply with the requirements of the study. 5. Must be a non-smoker or agree to smoke no more than 5 cigarettes (or equivalent) per day from Screening until Study Completion. Participants with mild HI (Group 2) 6. Participants must have a prior diagnosis of liver cirrhosis and mild HI as defined by the Child Pugh classification with a score of 5-6, inclusive (Class A) 7. Participants have been clinically stable and had no worsening of more than 1 point in Child Pugh score within 1 month prior to dosing of study treatment. 8. Seated vital signs m…
Read full criteria on CT.gov →✦ Analyst Commentary
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