A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-118 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- VX-118
- Conditions
- Cystic Fibrosis
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration Versus Time Curve (AUC) of VX-118
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of VX-118 in healthy 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.).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2), both inclusive
- •A total body weight greater than (\>) 50 kg
- •Participants of non-childbearing potential
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
- •Hypersensitivity to any component of the investigational drug product
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Sequence 1
Participants will receive a single dose of VX-118 as a suspension in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fed state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Intervention: VX-118
Sequence 2
Participants will receive a single dose of VX-118 as tablets in the fasted state in dosing period 1, followed by a single dose of VX-118 as tablets in the fed state in dosing period 2, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Intervention: VX-118
Sequence 3
Participants will receive a single dose of VX-118 as tablets in the fed state in dosing period 1, followed by a single dose of VX-118 as a suspension in the fasted state in dosing period 2, followed by a single dose of VX-118 as tablets in the fasted state in dosing period 3. A washout period of 8 days will be maintained between the 3 dosing periods.
Intervention: VX-118
Outcomes
Primary Outcomes
Area Under the Concentration Versus Time Curve (AUC) of VX-118
Time Frame: Pre-dose up to 192 hours Post-dose
Maximum Observed Plasma Concentration (Cmax) of VX-118
Time Frame: Pre-dose up to 192 hours Post-dose
Secondary Outcomes
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)(Day 1 up to Day 27)