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VX-118

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Vertex Pharmaceuticals Incorporated|Last Updated: Jun 3, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

VX-118 · 1 trial · 1 indication

Phase 1 1
NCT06312787A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet FormulationCystic Fibrosis
COMPLETED15 Analytics
PHASE1COMPLETED
A Study to Evaluate the Relative Bioavailability and Food Effect of a VX-118 Tablet Formulation
Cystic FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of VX-118
Pre-dose up to 192 hours Post-dose
Area Under the Concentration Versus Time Curve (AUC) of VX-118
Pre-dose up to 192 hours Post-dose

Secondary Endpoints

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Day 1 up to Day 27
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALParticipants 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.
Sequence 2EXPERIMENTALParticipants 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.
Sequence 3EXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
VX-118DRUGTablets and Suspension for Oral Administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key 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 Key Exclusion Criteria: * History of febrile illness or other acute illness that has not f...

Countries:United States
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Frequently asked questions about VX-118

What is VX-118 used for?

VX-118 is an investigational small molecule being developed for the treatment of cystic fibrosis. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes VX-118?

VX-118 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company listed on the NASDAQ under the ticker symbol VRTX.

What phase is VX-118 in?

VX-118 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 study has been completed.

What clinical trials is VX-118 in?

VX-118 has been studied in a completed Phase 1 clinical trial with the identifier NCT06312787. The trial evaluated the relative bioavailability and food effect of a VX-118 tablet formulation in healthy volunteers.

Is VX-118 the same as any other drug?

VX-118 is a distinct investigational compound developed by Vertex Pharmaceuticals. No alternative names for VX-118 have been disclosed in public clinical trial registries.