PainPhase 1NCT05455502
A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548
A Phase 1 study testing VX-548 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 relative bioavailability and food effect of a new tablet formulation of VX-548 in healthy adult 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?
- VX-548
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 17 Sep 2022
- 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 kg
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
- Female participants of childbearing potential
- Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
- History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease
- 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, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548 in Healthy Adult Subjects
The purpose of this study is to evaluate the relative bioavailability and food effect of a new tablet formulation of VX-548 in healthy adult 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
- VX-548
- 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
Tablet for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive VX-548 reference tablet (TF1) under fasted condition in dosing period 1, then VX-548 test tablet (TF2) under fasted condition in dosing period 2, and finally VX-548 test tablet (TF2) under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. Receives: Drug: VX-548 |
| Sequence 2 | Experimental | Participants will receive VX-548 TF1 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. Receives: Drug: VX-548 |
| Sequence 3 | Experimental | Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. Receives: Drug: VX-548 |
| Sequence 4 | Experimental | Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. Receives: Drug: VX-548 |
| Sequence 5 | Experimental | Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. Receives: Drug: VX-548 |
| Sequence 6 | Experimental | Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF2 under fasted condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. Receives: Drug: VX-548 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of VX-548
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548 Metabolite
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 Metabolite
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-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 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start13 Jul 2022
- Primary completion17 Sep 2022
- Study completion17 Sep 2022
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05455502
- Sponsor's protocol ID
- VX21-548-011
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 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, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05455502
- Acronym / sponsor ID
- VX21-548-011
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 13 Jul 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 relative bioavailability and food effect of a new tablet formulation of VX-548 in healthy adult participants.
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
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: VX-548Participants will receive VX-548 reference tablet (TF1) under fasted condition in dosing period 1, then VX-548 test tablet (TF2) under fasted condition in dosing period 2, and finally VX-548 test tablet (TF2) under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 2 | Experimental | Drug: VX-548Participants will receive VX-548 TF1 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 3 | Experimental | Drug: VX-548Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fed condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 4 | Experimental | Drug: VX-548Participants will receive VX-548 TF2 under fasted condition in dosing period 1, then VX-548 TF2 under fed condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 5 | Experimental | Drug: VX-548Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF1 under fasted condition in dosing period 2, and finally VX-548 TF2 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
| Sequence 6 | Experimental | Drug: VX-548Participants will receive VX-548 TF2 under fed condition in dosing period 1, then VX-548 TF2 under fasted condition in dosing period 2, and finally VX-548 TF1 under fasted condition in dosing period 3. A washout period of 12 days will be maintained between 3 dosing periods. |
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 kg
Key exclusion criteria (6 listed)
- 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
- Female participants of childbearing potential
- Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study
- History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease
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: SuzetrigineTablet for oral administration. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of VX-548
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of VX-548 Metabolite
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 Metabolite
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-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 40
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 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 2 inclusion and 6 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 VX-548 (time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144, up to 216 hours Post-dose). The study lists 3 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.