Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis

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NCT06154447

Sponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.

Phase

Phase 1

Status

Completed

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

165actual

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-12-12

actual

When the study began enrolling

Primary completion

2026-07-10

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-07-10

actual

The whole study's end, after follow-up

First posted

2023-12-04

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-10

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Cystic Fibrosis

Interventions

Drug: VX-828
Drug: Placebo
Drug: Itraconazole
Drug: Midazolam
Drug: Tezacaftor — also filed as TEZ, VX-661
Drug: VX-118
Drug: Placebo
Drug: Deutivacaftor — also filed as D-IVA, VX-561
Drug: VX-828

Primary outcomes

what the primary-completion date above is the date OF

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 67)

Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)

Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)

Part E: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Signing of Informed Consent Form (ICF) up to End of Study (Up to Day 111)

Part C: Maximum Observed Concentration (Cmax) of VX-828 in Plasma in the Absence and Presence of Itraconazole

measured From Day 1 up to Day 71

Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma in the Absence and Presence of Itraconazole

measured From Day 1 up to Day 71

Part C: Maximum Observed Concentration (Cmax) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVA

measured From Day 1 up to Day 30

Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVA

measured From Day 1 up to Day 30

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