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Completed

NCT Number: NCT05541471

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baltimore - Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-548

Drug

Tablets for oral administration.

Other names: Suzetrigine

midazolam

Drug

Syrup for oral administration.

Digoxin

Drug

Tablets for oral administration.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  1. 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

  2. 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

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

  3. Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) 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

  4. Renal Clearance (CLr) of Digoxin as Determined by Urine Analysis in the Absence and Presence of VX-548

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

  5. Fraction of Systematically Available Digoxin Dose Excreted Unchanged (fe) in Urine in the Absence and Presence of VX-548

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

  6. Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Day 39

  7. Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: Pre-dose up to Day 39

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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