A Phase 1 interventional study of VX-548 in Pain, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.
Drug: VX-548
Tablets for oral administration.
Also known as: Suzetrigine
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Time frame: 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
Time frame: 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
Time frame: Pre-dose up to Day 35 Post-dose
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 44
Plan to share: No — Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated