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Cardiac Glycoside

Arm 1 for Pain

Phase 1
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 and 19: pre-dose up to 120 hours post digoxin dose
Awards & highlights

Study Summary

This trial tests how drugs (midazolam & digoxin) are absorbed by the body when taken with a new drug (VX-548) or without it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 and 19: pre-dose up to 120 hours post digoxin dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 and 19: pre-dose up to 120 hours post digoxin dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
Digoxin
+3 more
Secondary outcome measures
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
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
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment3 Interventions
Participants will receive a single dose of midazolam and digoxin on Day 1 in dosing period 1 followed by VX-548 every 12 hours (q12h) on Days 6 through 23 in dosing period 2. On Day 19, single doses of midazolam and digoxin will be administered with the morning dose of VX-548.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-548
2022
Completed Phase 3
~3500
Midazolam
2018
Completed Phase 4
~1910
Digoxin
2017
Completed Phase 4
~670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,350 Total Patients Enrolled
14 Trials studying Pain
1,053 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin
2022. "A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05541471.
~14 spots leftby Apr 2025
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