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Clinical trial

A Phase 1, Randomized, Open-label, Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of VX-548 in Healthy Adults

ID
Name
VX22-548-016
Description
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.
Trial arms
Trial start
2023-05-03
Estimated PCD
2023-10-30
Trial end
2023-11-08
Status
Completed
Phase
Early phase I
Treatment
VX-548
Tablets for oral administration.
Arms:
VX-548
Other names:
Suzetrigine
Size
73
Primary endpoint
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Pre-dose up to Day 35 Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite
Pre-dose up to Day 35 Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Pre-dose up to Day 35 Post-dose
Eligibility criteria
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\^2) * A total body weight greater than (\>) 50 kilogram (kg) Key Exclusion Criteria: * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption * Participants of childbearing potential Other protocol defined Inclusion/Exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 73, 'type': 'ACTUAL'}}
Updated at
2024-03-20

1 organization

1 product

1 indication

Product
VX-548
Indication
Pain
Organization
Vertex Pharmaceuticals