Pain
Conditions
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.
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.).
Interventions
DRUGSuzetrigine
Tablet for oral administration.
DRUGEfavirenz
Tablet for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed