Clinical trial

A Phase 1, Open-label Study to Evaluate Pharmacokinetic Drug-drug Interactions Between VX-548 and Midazolam and Digoxin in Healthy Subjects

Name

VX21-548-010

Description

The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548.

Trial arms

Trial start

2022-09-22

Estimated PCD

2023-04-16

Trial end

2023-04-28

Status

Completed

Phase

Early phase I

Treatment

VX-548

Tablets for oral administration.

Arms:

Arm 1

Other names:

Suzetrigine

Midazolam

Syrup for oral administration.

Arms:

Arm 1

Digoxin

Tablets for oral administration.

Arms:

Arm 1

Size

Primary endpoint

Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-548

Days 1 and 19: Pre-dose up to 24 hours post midazolam dose

Maximum Observed Plasma Concentration (Cmax) of Digoxin in the Absence and Presence of VX-548

Days 1 and 19: Pre-dose up to 120 hours post digoxin dose

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Midazolam in the Absence and Presence of VX-548

Days 1 and 19: Pre-dose up to 24 hours post midazolam dose

Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Digoxin in the Absence and Presence of VX-548

Days 1 and 19: Pre-dose up to 120 hours post digoxin dose

Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Midazolam in the Absence and Presence of VX-548

Days 1 and 19: Pre-dose up to 24 hours post midazolam dose

Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Digoxin in the Absence and Presence of VX-548

Days 1 and 19: Pre-dose up to 120 hours post digoxin dose

Eligibility 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 greater than (\>) 50 kilogram (kg) * Females of non-childbearing potential Key Exclusion Criteria: * History of febrile illness or other acute illness that has not fully resolved within 5 days before the first dose of study drug * Any condition possibly affecting drug absorption * History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease * Hypersensitivity to midazolam, other benzodiazepines, or digoxin Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

Updated at

2024-03-20

1 organization

3 products

1 indication

Organization

Vertex Pharmaceuticals

Product

Indication

Product

Product