A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin

Vertex Pharmaceuticals Incorporated37 enrolled

Overview

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

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

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pain

Interventions

VX-548DRUG

Tablets for oral administration.

MidazolamDRUG

Syrup for oral administration.

DigoxinDRUG

Tablets for oral administration.

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 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.

Locations (1)

Baltimore - Early Phase Clinical Unit

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax) of 1-hydroxy-Midazolam in the Absence and Presence of VX-548

Time frame: 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 1-hydroxy-Midazolam in the Absence and Presence of VX-548

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.