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PainPhase 1NCT06336096

A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine

A Phase 1 study testing Suzetrigine in people with Pain, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants. 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?
Suzetrigine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
28 Mar 2024to 19 Jun 2024
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)
  • Participants of non-childbearing potential

Who cannot join

  • History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion - Tempe

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of Suzetrigine in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants.

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
Suzetrigine
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SuzetrigineDrug

    Also called VX-548, SUZ

    Tablet(s) for oral administration.

  • SuzetrigineDrug

    Also called VX-548, SUZ

    Tablet(s) and Suspension for oral administration.

Study groups in NCT06336096
Study groupRoleWhat they receive
Part AExperimentalParticipants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period.
Receives: Drug: Suzetrigine
Part BExperimentalParticipants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period.
Receives: Drug: Suzetrigine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ

    Measured: Pre-dose up to Day 43

  2. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ

    Measured: Pre-dose up to Day 43

  3. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ

    Measured: Pre-dose up to Day 43

  4. Part B: Cmax of SUZ

    Measured: Pre-dose up to Day 29

  5. Part B: AUC0-tlast of SUZ

    Measured: Pre-dose up to Day 29

  6. Part B: AUC0-inf of SUZ

    Measured: Pre-dose up to Day 29

Secondary outcomes (8)

  1. Part A: Cmax of SUZ Metabolite

    Measured: Pre-dose up to Day 43

  2. Part A: AUC0-tlast of SUZ Metabolite

    Measured: Pre-dose up to Day 43

  3. Part A: AUC0-inf of SUZ Metabolite

    Measured: Pre-dose up to Day 43

  4. Part A: 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 43

  5. Part B: Cmax of SUZ Metabolite

    Measured: Pre-dose up to Day 29

  6. Part B: AUC0-tlast of SUZ Metabolite

    Measured: Pre-dose up to Day 29

  7. Part B: AUC0-inf of SUZ Metabolite

    Measured: Pre-dose up to Day 29

  8. Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs

    Measured: From Day 1 up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start28 Mar 2024
  3. Primary completion19 Jun 2024
  4. Study completion19 Jun 2024

Resources

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
Crossover
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06336096
Sponsor's protocol ID
VX23-548-017
Status last verified
Jul 2024
First submitted
21 Mar 2024
Last updated
19 Jul 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Suzetrigine 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 3 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 19 Jul 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?

Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ (time frame: Pre-dose up to Day 43). 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?

On the ClinicalTrials.gov record for NCT06336096.

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 19 Jul 2024.

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