View clinical trials related to Hepatic Impairment.
Filter by:This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic function. Participants will be enrolled within the following groups based on their CP classification score as determined at screening: - Group 1: Matched-control healthy participants with normal hepatic function. - Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). - Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
This study will be conducted in 2 parts. Part 1 will comprise of participants with mild and moderate HI and matching healthy control participants with normal hepatic function. Part 2 will comprise of participants with severe HI and matching healthy control participants with normal hepatic function. Each study part will comprise of a screening period of up to 28 days, a baseline evaluation on Day -1, and a treatment period including up to 8 days of safety and PK data collection. Participants will be domiciled from Day -1 through Day 8. All participants will receive 25 mg remibrutinib b.i.d. orally on Days 1 and 2, and a morning oral dose of 25 mg remibrutinib on Day 3. PK samples will be collected pre dose on Day 3 and until 72 hours post Day 3 dosing. Throughout the study, safety assessments will include physical examinations, ECGs, vital signs, clinical laboratory evaluations (hematology, chemistry, urinalysis and coagulation) and AE / serious adverse event (SAE) monitoring. The Investigator and Novartis will conduct a joint interim review of safety and PK data from Part 1 before proceeding to Part 2. Part 2 will only begin if administration of remibrutinib in Part 1 is deemed safe and tolerable by the Investigator and Novartis to proceed in participants with severe HI. Depending on the outcome of the interim review, administration of a lower dose of remibrutinib in severe HI participants and their matching healthy control participants may be considered. Part 2 will also include sentinel dosing where one participant with severe HI will receive the first dose of remibrutinib at least 1 week before the remaining participants. If the Investigator concludes that there are no emergent safety concerns for the sentinel participant, then dosing will commence for the remaining participants. Study Completion evaluations will occur on Day 8, followed by a post-study safety follow up contact (e.g. follow-up telephone call, email) approximately 30 days after the last administration of study treatment. The total study duration for each participant is expected to be up to approximately 62 days, including the Screening period and the follow-up contact.
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of mitiperstat.
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
The primary objective is to assess the PK of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single SC dose administration.
This is an Open-Label, Parallel, Single-dose, Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Orelabrutinib Tablets in Subjects with Varying Degrees of Hepatic Impairment
The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child Pugh classification) on the plasma PK of siremadlin after a single oral dose. In addition, safety and tolerability of siremadlin after a single oral dose will be evaluated. The results of this study will inform the decision whether a dose adjustment may be recommended when treating patients with various degrees of impaired hepatic function.