VX-548
DrugTablets for oral administration.
Other names: Suzetrigine
NCT Number: NCT05560464
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Division of Clinical Pharmacology, University of Miami, Miami, Florida, United States
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.).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Tablets for oral administration.
Other names: Suzetrigine
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 1 to Day 31
Time frame: Day 14: Up to 24 hours Post-dose
Time frame: Day 14: Up to 24 hours Post-dose
Time frame: From Day 1 up to Day 42
Vertex Pharmaceuticals Incorporated
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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