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Active, Not Recruiting

NCT Number: NCT07570069

Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON - Utah - Salt Lake City Office

Salt Lake City, Utah, 84124, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suzetrigine

Drug

Tablet for oral administration.

Other names: SUZ, Journavx

Efavirenz

Drug

Tablet for oral administration.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz

    Time frame: Day 15 and Day 30

  2. Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCτ) of SUZ and its Metabolite in the Absence and Presence of Efavirenz

    Time frame: 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)

    Time frame: From Day 1 up to Day 46

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
Jun 30, 2026

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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