A Phase 1, First-in-human Study of VX-433

Phase 1RecruitingNCT07584434

Vertex Pharmaceuticals Incorporated118 enrolled

Overview

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.

The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C). Note: 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.).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

118

Conditions

Narcolepsy Type 1 (NT1)

Interventions

VX-433DRUG

Suspension for Oral Administration

PlaceboDRUG

Suspension for Oral Administration

MidazolamDRUG

Syrup for Oral Administration

Bupropion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m2), inclusive * 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 that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption * For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug Other protocol defined Inclusion/Exclusion criteria will apply.

Locations (1)

ICON - Utah - Salt Lake City Office

Salt Lake City, Utah, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: From Day 1 up to Day 6

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

Time frame: From Day 1 up to Day 18

Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433

Time frame: From Day 1 up to Day 22

Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433

Time frame: From Day 1 up to Day 22

Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-433

Time frame: From Day 1 up to Day 22

Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433

Time frame: From Day 1 up to Day 22

Secondary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433

Time frame: From Day 1 up to Day 6

Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433

Time frame: From Day 1 up to Day 18

Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433

Time frame: From Day 1 up to Day 6

Central Contacts

Medical Information

CONTACT

617-341-6777 medicalinfo@vrtx.com

Data from ClinicalTrials.gov

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