PainPhase 1NCT06820307
Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants
A Phase 1 study testing Suzetrigine, DRSP/EE and NGM/EE 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 effect of SUZ on the pharmacokinetics of oral contraceptives. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Suzetrigine, DRSP/EE and NGM/EE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 29 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 18.0 to 30.0 kilogram per meter square (Kg/m^2)
- A total body weight greater than (>) 50 kilogram (kg)
- Nonsmoker or ex-smoker for at least 12 months before screening
Who cannot join
- History of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
- Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include, but is not limited to, intolerance to hormonal contraceptives; hypertension; history of deep vein thrombosis; coronary artery disease; cardiovascular disease; systemic lupus erythematosus; migraine; history of breast or cervical cancer; cirrhosis; and history of liver cancer.
- Other protocol defined Inclusion/Exclusion criteria will apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.
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, DRSP/EE, NGM/EE
- 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
Tablets for Oral Administration.
DRSP/EEDrug
Combination Tablets for Oral Administration.
NGM/EEDrug
Combination Tablets for Oral Administration.
| Study group | Role | What they receive |
|---|---|---|
| Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) | Experimental | Participants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25. Receives: Drug: Suzetrigine; Drug: DRSP/EE |
| Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) | Experimental | Participants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29. Receives: Drug: Suzetrigine; Drug: NGM/EE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ
Measured: Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of SUZ
Measured: Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of DRSP and EE in the Absence and Presence of SUZ
Measured: Pre-dose up to Day 25 Post-dose
Part B: Maximum Observed Plasma Concentration (Cmax) of NGM Metabolites and EE in the Absence and Presence of SUZ
Measured: Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NGM Metabolites and EE in the Absence and Presence of SUZ
Measured: Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of NGM Metabolites and EE in the Absence and Presence of SUZ
Measured: Pre-dose up to Day 29 Post-dose
Secondary outcomes (2)
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 40
Part B: 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 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start25 Feb 2025
- Primary completion29 Apr 2025
- Study completion29 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT06820307
- Sponsor's protocol ID
- VX24-548-019
- Status last verified
- May 2025
- First submitted
- 5 Feb 2025
- Last updated
- 29 May 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Effect of Suzetrigine on the Pharmacokinetics of Oral Contraceptives in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT06820307
- Acronym / sponsor ID
- VX24-548-019
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 11 Feb 2025 (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 effect of SUZ on the pharmacokinetics of oral contraceptives.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) | Experimental | Drug: Suzetrigine, Drug: DRSP/EEParticipants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25. |
| Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) | Experimental | Drug: Suzetrigine, Drug: NGM/EEParticipants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index of 18.0 to 30.0 kilogram per meter square (Kg/m^2)
- A total body weight greater than (>) 50 kilogram (kg)
- Nonsmoker or ex-smoker for at least 12 months before screening
Key exclusion criteria (4 listed)
- History of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
- Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include, but is not limited to, intolerance to hormonal contraceptives; hypertension; history of deep vein thrombosis; coronary artery disease; cardiovascular disease; systemic lupus erythematosus; migraine; history of breast or cervical cancer; cirrhosis; and history of liver cancer.
- Other protocol defined Inclusion/Exclusion criteria will 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 |
|---|---|---|
| SuzetrigineAlso: VX-548, SUZTablets for Oral Administration. | Drug | Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE), Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) |
| DRSP/EECombination Tablets for Oral Administration. | Drug | Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE) |
| NGM/EECombination Tablets for Oral Administration. | Drug | Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE) |
Primary outcome
Part A: Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of SUZ
Time frame: Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of SUZ
Time frame: Pre-dose up to Day 25 Post-dose
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of DRSP and EE in the Absence and Presence of SUZ
Time frame: Pre-dose up to Day 25 Post-dose
Part B: Maximum Observed Plasma Concentration (Cmax) of NGM Metabolites and EE in the Absence and Presence of SUZ
Time frame: Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NGM Metabolites and EE in the Absence and Presence of SUZ
Time frame: Pre-dose up to Day 29 Post-dose
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of NGM Metabolites and EE in the Absence and Presence of SUZ
Time frame: Pre-dose up to Day 29 Post-dose
2 secondary outcomes
Part A: 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 40
Part B: 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 44
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 29 May 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 Suzetrigine, DRSP/EE and NGM/EE 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 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 29 May 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 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 DRSP and EE in the Absence and Presence of SUZ (time frame: Pre-dose up to Day 25 Post-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 29 May 2025.