A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-993
- Registration Number
- NCT06508762
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-993 in healthy adult participants.
- Detailed Description
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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive
- A total body weight of more than (>) 50 kg
- Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug
Key
Exclusion Criteria
- History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VX-993 VX-993 Participants will be randomized to receive VX-993 in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two VX-993 formulations and the effect of food on the pharmacokinetics of VX-993.
- Primary Outcome Measures
Name Time Method Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 From Day 1 up to Day 28 Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993 From Day 1 up to Day 28 Maximum Observed Plasma Concentration (Cmax) of VX-993 From Day 1 up to Day 28
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of VX-993 Metabolite From Day 1 up to Day 28 Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of VX-993 Metabolite From Day 1 up to Day 28 Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-993 Metabolite From Day 1 up to Day 28 Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to Day 28
Trial Locations
- Locations (1)
ICON Salt Lake City
🇺🇸Salt Lake City, Utah, United States