Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants

NCT07570069 — Phase 1, Completed, 18 participants, Vertex Pharmaceuticals Incorporated

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A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Subjects

Registry	NCT07570069
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	18 (Actual)
Sponsor	Vertex Pharmaceuticals Incorporated (Industry)
Conditions	Pain
Interventions	Suzetrigine, Efavirenz (Drug)
Dates	start 2026-05-07, primary completion 2026-07-16, completion 2026-07-16, first posted 2026-05-06, last updated 2026-08-18
Locations	1 site in United States

-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.

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+Detailed 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 deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

+Arms and interventions

Arm	Type	Interventions	Description
SUZ and Efavirenz	Experimental	Drug: Suzetrigine; Drug: Efavirenz	Participants will receive a single dose of SUZ on Days 1 through 15. Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30.

Suzetrigine (Drug), also known as SUZ, Journavx: Tablet for oral administration.
Efavirenz (Drug): Tablet for oral administration.

+Outcome measures

Primary outcomes

Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz [Day 15 and Day 30]
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCτ) of SUZ and its Metabolite in the Absence and Presence of Efavirenz [Day 15 and Day 30]

Secondary outcomes

Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Day 1 up to Day 46]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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 Inclusion/Exclusion criteria may apply.

+Locations (1)

Facility	City	Country	Status
ICON - Utah - Salt Lake City Office	Salt Lake City, Utah	United States

My Notes

Public

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