PainPhase 1NCT05704556
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Renal Impairment
A Phase 1 study testing VX-548 in people with Pain, run by Vertex Pharmaceuticals Incorporated at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 38 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Feb 2023to 30 Mar 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
- Body mass index (BMI) of greater than or equal to (>=)18.0 to less than (<) 40.0 kilogram per square meter (kg/m^2)
- Stable renal function as pre-defined in the protocol
- Cohorts 2 and 4: Matched Healthy Participants
- Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)
Who cannot join
- Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
- Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening
- Cohorts 2 and 4: Matched Healthy Participants
- Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis
- All Cohorts:
- History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing.
- Any condition possibly affecting drug absorption
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Infigo Clinical Research
DeLand, Florida, 32720
Southwest Houston Research, Ltd
Houston, Texas, 77099
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
GCP Research
St. Petersburg, Florida, 33705
Genesis Clinical Research
Tampa, Florida, 33603
Elixia, Phase 1 Clinical Site
Tampa, Florida, 33618
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Single Doses of VX-548 in Subjects With Severe or Moderate Renal Impairment and in Matched Healthy Subjects
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and 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
- 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
Tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | Participants will receive a single dose of VX-548 in a fasted state. Receives: Drug: VX-548 |
| Cohort 2: Matched Healthy Participants | Experimental | Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state. Receives: Drug: VX-548 |
| Cohort 3: Moderate Renal Impairment | Experimental | Participants will receive a single dose of VX-548 in a fasted state. Receives: Drug: VX-548 |
| Cohort 4: Matched Healthy Participants | Experimental | Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state. 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 and its Metabolite
Measured: Day 1 to Day 14
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Measured: Day 1 to Day 14
Secondary outcomes (6)
Apparent Clearance of VX-548
Measured: Day 1 to Day 14
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
Measured: Day 1 to Day 14
Apparent Non-Renal Clearance of VX-548
Measured: Day 1 to Day 14
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 to Day 23
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Measured: Day 1 to Day 2
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start27 Feb 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
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
- 38 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
- NCT05704556
- Sponsor's protocol ID
- VX22-548-014
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2023
- Last updated
- 29 Apr 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Single Doses of VX-548 in Subjects With Severe or Moderate Renal Impairment and in Matched Healthy Subjects
- ClinicalTrials.gov ID
- NCT05704556
- Acronym / sponsor ID
- VX22-548-014
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 30 Jan 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 this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and healthy 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | Drug: VX-548Participants will receive a single dose of VX-548 in a fasted state. |
| Cohort 2: Matched Healthy Participants | Experimental | Drug: VX-548Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state. |
| Cohort 3: Moderate Renal Impairment | Experimental | Drug: VX-548Participants will receive a single dose of VX-548 in a fasted state. |
| Cohort 4: Matched Healthy Participants | Experimental | Drug: VX-548Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
- Cohorts 2 and 4: Matched Healthy Participants
Key exclusion criteria (8 listed)
- Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
- Cohorts 2 and 4: Matched Healthy Participants
- All Cohorts:
- 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 | Cohort 1: Severe Renal Impairment, Cohort 2: Matched Healthy Participants, Cohort 3: Moderate Renal Impairment, Cohort 4: Matched Healthy Participants |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Time frame: Day 1 to Day 14
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Time frame: Day 1 to Day 14
6 secondary outcomes
Apparent Clearance of VX-548
Time frame: Day 1 to Day 14
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
Time frame: Day 1 to Day 14
Apparent Non-Renal Clearance of VX-548
Time frame: Day 1 to Day 14
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 23
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Time frame: Day 1 to Day 2
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Time frame: Day 1 to Day 14
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 Apr 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.
7 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 in people with Pain, run by Vertex Pharmaceuticals Incorporated at 7 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 5 inclusion and 8 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite (time frame: Day 1 to Day 14). The study lists 2 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 Apr 2024.