A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Subjects
Vertex Pharmaceuticals Incorporated
Summary
The purpose of the study is to evaluate the pharmacokinetics (PK) of Suzetrigine (SUZ) and its metabolite in the absence and presence of efavirenz, a moderate CYP3A inducer. In addition, the purpose is to evaluate the safety and tolerability of SUZ when administered in the absence and presence of efavirenz.
Description
The study is being conducted to evaluate the effects of efavirenz on the PK of SUZ in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Participants will receive study medication for a duration of 30 days. Note: 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 deadlin…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of greater than (\>) 50 kg * Males and females of non-childbearing potential Key Exclusion Criteria: * History of any illness or any clinical condition that may confound the results of the study or pose an additional risk in administering study drug to the participant * History of febrile illness or other acute illness that has not fully resolved within 5 days before the first dose of study drug * Any condition possibly affecting drug absorption Other protocol defined I…
Interventions
- DrugSuzetrigine
Tablet for oral administration.
- DrugEfavirenz
Tablet for oral administration.
Location
- ICON - Utah - Salt Lake City OfficeSalt Lake City, Utah