PainPhase 1NCT05541471
A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin
A Phase 1 study testing VX-548, Midazolam and Digoxin in people with Pain, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- VX-548, Midazolam and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 28 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore - Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase 1, Open-label Study to Evaluate Pharmacokinetic Drug-drug Interactions Between VX-548 and Midazolam and Digoxin in Healthy Subjects
The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548.
Read the detailed description
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.).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-548Drug
Also called Suzetrigine
Tablets for oral administration.
MidazolamDrug
Syrup for oral administration.
DigoxinDrug
Tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Drug: VX-548; Drug: Midazolam; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-548
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Days 1 and 19: Pre-dose up to 120 hours post digoxin dose
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of 1-hydroxy-Midazolam in the Absence and Presence of VX-548
Measured: 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
Measured: 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 1-hydroxy-Midazolam in the Absence and Presence of VX-548
Measured: Days 1 and 19: Pre-dose up to 24 hours post midazolam dose
Renal Clearance (CLr) of Digoxin as Determined by Urine Analysis in the Absence and Presence of VX-548
Measured: Days 1 and 19: Pre-dose up to 120 hours post digoxin dose
Fraction of Systematically Available Digoxin Dose Excreted Unchanged (fe) in Urine in the Absence and Presence of VX-548
Measured: Days 1 and 19: Pre-dose up to 120 hours post digoxin dose
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 up to Day 39
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Measured: Pre-dose up to Day 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start22 Sep 2022
- Primary completion16 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541471
- Sponsor's protocol ID
- VX21-548-010
- Status last verified
- Mar 2024
- First submitted
- 12 Sep 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate Pharmacokinetic Drug-drug Interactions Between VX-548 and Midazolam and Digoxin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05541471
- Acronym / sponsor ID
- VX21-548-010
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 16 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: VX-548, Drug: Midazolam, Drug: DigoxinParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-548Also: SuzetrigineTablets for oral administration. | Drug | Arm 1 |
| MidazolamSyrup for oral administration. | Drug | Arm 1 |
| DigoxinTablets for oral administration. | Drug | Arm 1 |
Primary outcome
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
7 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
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 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
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
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
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
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Pre-dose up to Day 39
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VX-548, Midazolam and Digoxin in people with Pain, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.