A Phase 1, First-in-human Study of VX-828

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: VX-828; Drug: Placebo; Drug: Midazolam; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT06154447

VX23-828-001

Details and patient eligibility

About

The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 in healthy participants.

Full 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.).

Enrollment: 159 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 more than (>) 50 kg
• Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening

Key Exclusion Criteria:

• History of febrile illness or other acute illness within 14 days before the first dose of study drug
• Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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159 participants in 5 patient groups, including a placebo group

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

Participants will be randomized to receive a single dose of different dose levels of VX-828.

Treatment:

Drug: VX-828

Part A: Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive placebo matched to VX-828.

Treatment:

Drug: Placebo

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

Participants will be randomized to receive multiple doses of different dose levels of VX-828. The dose levels will be determined based on the data from Part A.

Treatment:

Drug: VX-828

Part B: Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive placebo matched to VX-828.

Treatment:

Drug: Placebo

Part C: Drug Drug Interaction

Experimental group

Description:

Participants will receive a single dose of VX-828, followed by a washout period, Itraconazole administration, and concomitant administration of itraconazole and VX-828; or participants will receive Midazolam followed by VX-828 administration, and concomitant administration of VX-828 and Midazolam. Part C will be an open-label optional cohort.

Treatment:

Drug: Itraconazole

Drug: Midazolam

Drug: VX-828