Arm 1 for Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pain
Midazolam - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pain

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: Days 1 and 19: Pre-dose up to 120 hours post digoxin dose

Day 39
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1
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
Digoxin
Fraction of Systematically Available Digoxin Dose Excreted Unchanged (fe) in Urine in the Absence and Presence of VX-548
Maximum Observed Plasma Concentration (Cmax) of Digoxin in the Absence and Presence of VX-548
Renal Clearance (CLr) of Digoxin as Determined by Urine Analysis in the Absence and Presence of VX-548
Day 1
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 Extrapolated to Infinity (AUC0-inf) of 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
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
Maximum Observed Plasma Concentration (Cmax) of 1-hydroxy-Midazolam in the Absence and Presence of VX-548
Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-548
Day 39
Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Trial Safety

Safety Progress

1 of 3

Other trials for Pain

Trial Design

1 Treatment Group

Arm 1
1 of 1
Experimental Treatment

23 Total Participants · 1 Treatment Group

Primary Treatment: Arm 1 · No Placebo Group · Phase 1

Arm 1Experimental Group · 3 Interventions: Midazolam, VX-548, Digoxin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1920
VX-548
2021
Completed Phase 2
~610
Digoxin
2017
Completed Phase 4
~670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 1 and 19: pre-dose up to 120 hours post digoxin dose

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
215 Previous Clinical Trials
29,894 Total Patients Enrolled
4 Trials studying Pain
159 Patients Enrolled for Pain

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) of 18.0 to 32.0 Kg/m^2.
You are 50 kilograms or more over your total body weight.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.