PainPhase 1NCT05818852
A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
A Phase 1 study testing VX-548 and Moxifloxacin in people with Pain, run by Vertex Pharmaceuticals Incorporated at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite. 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 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2023to 28 Jun 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)
Who cannot join
- History of febrile illness within 5 days before the first dose of study drug
- Any condition possibly affecting drug absorption
- Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON Lenexa
Lenexa, Kansas, 66219
ICON Salt Lake City
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects
The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.
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.).
- Conditions
- Pain
- Being tested
- VX-548, Moxifloxacin, Moxifloxacin Placebo, VX-548 Placebo
- Medical subject headings
- Pain
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.
MoxifloxacinDrug
Capsules for oral administration.
Moxifloxacin PlaceboDrug
Capsules for oral administration.
VX-548 PlaceboDrug
Tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. Receives: Drug: VX-548; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo |
| Group 2A | Active comparator | Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. Receives: Drug: Moxifloxacin; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo |
| Group 2B | Active comparator | Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. Receives: Drug: Moxifloxacin; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT interval corrected by Fridericia's formula (QTcF)
Measured: From Baseline up to Day 12
Secondary outcomes (15)
Change in Heart Rate (HR)
Measured: From Baseline up to Day 12
Change in PR interval, segment
Measured: From Baseline up to Day 12
Change in QRS duration
Measured: From Baseline up to Day 12
Placebo-corrected Change in QTcF
Measured: From Baseline up to Day 12
Placebo-corrected Change in HR
Measured: From Baseline up to Day 12
Placebo-corrected Change in PR interval
Measured: From Baseline up to Day 12
Placebo-corrected Change in QRS duration
Measured: From Baseline up to Day 12
Number of Outliers for QTcF
Measured: From Baseline up to Day 12
Number of Outliers for HR
Measured: From Baseline up to Day 12
Number of Outliers for PR interval
Measured: From Baseline up to Day 12
Number of Outliers for QRS duration
Measured: From Baseline up to Day 12
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
Measured: From Baseline up to Day 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to Day 26
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Measured: Days 6 and 10: Pre-dose up to 24 hours
Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite
Measured: Days 6 and 10: Pre-dose up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start12 Apr 2023
- Primary completion12 Jun 2023
- Study completion28 Jun 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT05818852
- Sponsor's protocol ID
- VX21-548-009
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2023
- 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, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05818852
- Acronym / sponsor ID
- VX21-548-009
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 19 Apr 2023 (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 the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: VX-548, Drug: Moxifloxacin Placebo, Drug: VX-548 PlaceboParticipants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. |
| Group 2A | Active comparator | Drug: Moxifloxacin, Drug: Moxifloxacin Placebo, Drug: VX-548 PlaceboParticipants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. |
| Group 2B | Active comparator | Drug: Moxifloxacin, Drug: Moxifloxacin Placebo, Drug: VX-548 PlaceboParticipants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 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)
Key exclusion criteria (4 listed)
- History of febrile illness within 5 days before the first dose of study drug
- Any condition possibly affecting drug absorption
- Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones
- 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 | Group 1 |
| MoxifloxacinCapsules for oral administration. | Drug | Group 2A, Group 2B |
| Moxifloxacin PlaceboCapsules for oral administration. | Drug | Group 1, Group 2A, Group 2B |
| VX-548 PlaceboTablets for oral administration. | Drug | Group 1, Group 2A, Group 2B |
Primary outcome
Change in QT interval corrected by Fridericia's formula (QTcF)
Time frame: From Baseline up to Day 12
15 secondary outcomes
Change in Heart Rate (HR)
Time frame: From Baseline up to Day 12
Change in PR interval, segment
Time frame: From Baseline up to Day 12
Change in QRS duration
Time frame: From Baseline up to Day 12
Placebo-corrected Change in QTcF
Time frame: From Baseline up to Day 12
Placebo-corrected Change in HR
Time frame: From Baseline up to Day 12
Placebo-corrected Change in PR interval
Time frame: From Baseline up to Day 12
Placebo-corrected Change in QRS duration
Time frame: From Baseline up to Day 12
Number of Outliers for QTcF
Time frame: From Baseline up to Day 12
Number of Outliers for HR
Time frame: From Baseline up to Day 12
Number of Outliers for PR interval
Time frame: From Baseline up to Day 12
Number of Outliers for QRS duration
Time frame: From Baseline up to Day 12
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
Time frame: From Baseline up to Day 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 26
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Time frame: Days 6 and 10: Pre-dose up to 24 hours
Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite
Time frame: Days 6 and 10: Pre-dose up to 24 hours
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
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
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.
2 sites 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 and Moxifloxacin in people with Pain, run by Vertex Pharmaceuticals Incorporated at 2 sites 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 2 inclusion and 4 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 2 sites 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?
Change in QT interval corrected by Fridericia's formula (QTcF) (time frame: From Baseline up to Day 12). 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.