PainPhase 1NCT06420765
A Microneurography Study of NaV1.8 Inhibition in Healthy Adults
A Phase 1 study testing VX-150, VX-548 and VX-993 in people with Pain, run by Vertex Pharmaceuticals Incorporated at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150, VX-993 and VX-548. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- VX-150, VX-548 and VX-993
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 May 2024to 4 Apr 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2)
- A total body weight of more than (>) 50 kg
Who cannot join
- History of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing
- Any condition possibly affecting drug absorption
- Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability
- Participants with Type 1 or Type 2 diabetes mellitus
- Participants who have any 1 of the following criteria in the foot in which microneurography (MNG) will be performed:
- Injection of local anesthetics or steroids within 35 days prior to randomization.
Show all 9Show fewer
- Unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot)
- Infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments Note: Participants must have 1 foot that does not meet any of the above criteria to be eligible.
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Effects of Single Doses of NaV1.8 Inhibitors on C-Nociceptor Action Potentials in Healthy Adults
The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150, VX-993 and 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.).
- Conditions
- Pain
- Being tested
- VX-150, VX-548, VX-993, 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-150Drug
Suspension for oral administration.
VX-548Drug
Solution or suspension for oral administration.
VX-993Drug
Suspension for oral administration.
PlaceboDrug
Suspension for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| VX-150 | Experimental | Participants will be randomized to receive a single dose of VX-150. Receives: Drug: VX-150 |
| VX-548 | Experimental | Participants will be randomized to receive a single dose of different dose levels of VX-548 Receives: Drug: VX-548 |
| VX-993 | Experimental | Participants will be randomized to receive a single dose of different dose levels of VX-993. Receives: Drug: VX-993 |
| Placebo | Placebo comparator | Participants will receive single dose of non-matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Activity Dependent Slowing (ADS) Over Time
Measured: From Pre-dose up to 2-hours Post Dose
Secondary outcomes (3)
Change From Baseline in Conduction Velocity at 0.25 Hz Over Time
Measured: From Pre-dose up to 2-hours Post Dose
Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time
Measured: From Pre-dose up to 2-hours Post Dose
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
Measured: From Day 1 up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start21 May 2024
- Primary completion22 Mar 2025
- Study completion4 Apr 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 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
- NCT06420765
- Sponsor's protocol ID
- VX23-PMI-001
- Status last verified
- Apr 2025
- First submitted
- 14 May 2024
- Last updated
- 20 Apr 2025
- 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Effects of Single Doses of NaV1.8 Inhibitors on C-Nociceptor Action Potentials in Healthy Adults
- ClinicalTrials.gov ID
- NCT06420765
- Acronym / sponsor ID
- VX23-PMI-001
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 20 May 2024 (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 determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150, VX-993 and 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VX-150 | Experimental | Drug: VX-150Participants will be randomized to receive a single dose of VX-150. |
| VX-548 | Experimental | Drug: VX-548Participants will be randomized to receive a single dose of different dose levels of VX-548 |
| VX-993 | Experimental | Drug: VX-993Participants will be randomized to receive a single dose of different dose levels of VX-993. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive single dose of non-matching placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2)
- A total body weight of more than (>) 50 kg
Key exclusion criteria (9 listed)
- History of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing
- Any condition possibly affecting drug absorption
- Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability
- Participants with Type 1 or Type 2 diabetes mellitus
- Participants who have any 1 of the following criteria in the foot in which microneurography (MNG) will be performed:
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-150Suspension for oral administration. | Drug | VX-150 |
| VX-548Solution or suspension for oral administration. | Drug | VX-548 |
| VX-993Suspension for oral administration. | Drug | VX-993 |
| PlaceboSuspension for oral administration. | Drug | Placebo |
Primary outcome
Change From Baseline in Activity Dependent Slowing (ADS) Over Time
Time frame: From Pre-dose up to 2-hours Post Dose
3 secondary outcomes
Change From Baseline in Conduction Velocity at 0.25 Hz Over Time
Time frame: From Pre-dose up to 2-hours Post Dose
Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time
Time frame: From Pre-dose up to 2-hours Post Dose
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
Time frame: From Day 1 up to Day 16
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 Apr 2025.
- 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-150, VX-548 and VX-993 in people with Pain, run by Vertex Pharmaceuticals Incorporated at 1 site in United Kingdom.
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 9 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 Apr 2025. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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 From Baseline in Activity Dependent Slowing (ADS) Over Time (time frame: From Pre-dose up to 2-hours Post Dose). 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 Apr 2025.