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Clinical trial

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of VX-548 in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects

ID
Name
VX21-548-007
Description
The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.
Trial arms
Trial start
2022-10-14
Estimated PCD
2023-07-24
Trial end
2023-07-24
Status
Completed
Phase
Early phase I
Treatment
VX-548
Tablets for oral administration.
Arms:
Cohort 1: Mild Hepatic Impairment, Cohort 2: Matched Healthy Participants, Cohort 3: Moderate Hepatic Impairment, Cohort 4: Matched Healthy Participants
Other names:
Suzetrigine
Size
36
Primary endpoint
Maximum Observed Plasma Concentration (Cmax) of VX-548
Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Day 1 to Day 31
Time Taken for VX-548 to Reach Maximum Concentration (tmax)
Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2)
Day 1 to Day 31
Apparent Volume of Distribution of VX-548 (Vz/F)
Day 1 to Day 31
Apparent Clearance of VX-548 (CL/F)
Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548
Day 1 to Day 31
Eligibility criteria
Key Inclusion Criteria: * Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment * Participants will satisfy the criteria for mild (Cohort 1) and moderate hepatic impairment (Cohort 3) defined as a Child-Pugh total score of 5 to 6 and 7 to 9 points, respectively at the screening visit * Participants will have chronic (greater than or equal to (≥) 6 months) documented liver disease * Cohorts 2 and 4: Matched Healthy Participants * Participants will be matched (cohort 2 matched to cohort 1; and cohort 4 matched to cohort 3) during screening to participants with hepatic impairment for age, sex, and weight Key Exclusion Criteria: * Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment * History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug * Severe portal hypertension * History or presence of severe hepatic encephalopathy (Grade \>2) * Any condition possibly affecting drug absorption * Significant renal dysfunction (creatinine clearance \<60 milliliter per minute \[mL/min\] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1 * History of solid organ or bone marrow transplantation * Cohorts 2 and 4: Matched Healthy Participants * History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug * Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}
Updated at
2024-03-20

1 organization

1 product

1 indication

Organization
Vertex Pharmaceuticals
Product
VX-548
Indication
Pain