Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants

NCT07570069 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: VX24-548-018
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• 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

Study Arms (1)

SUZ and Efavirenz

EXPERIMENTAL

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.

Drug: Suzetrigine; Drug: Efavirenz

Interventions

Suzetrigine DRUG

Tablet for oral administration.

Also known as: SUZ, Journavx

SUZ and Efavirenz

Efavirenz DRUG

Tablet for oral administration.

SUZ and Efavirenz

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

MeSH Terms

Conditions

Pain

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share