PainPhase 1NCT05560464
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment
A Phase 1 study testing VX-548 in people with Pain, run by Vertex Pharmaceuticals Incorporated at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2022to 24 Jul 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
- Participants will satisfy the criteria for mild (Cohort 1) and moderate hepatic impairment (Cohort 3) defined as a Child-Pugh total score of 5 to 6 and 7 to 9 points, respectively at the screening visit
- Participants will have chronic (greater than or equal to (≥) 6 months) documented liver disease
- Cohorts 2 and 4: Matched Healthy Participants
- Participants will be matched (cohort 2 matched to cohort 1; and cohort 4 matched to cohort 3) during screening to participants with hepatic impairment for age, sex, and weight
Who cannot join
- Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
- History of febrile illness or other acute illness that has not fully resolved by 14 days before the first dose of study drug
- Severe portal hypertension
- History or presence of severe hepatic encephalopathy (Grade >2)
- Any condition possibly affecting drug absorption
- Significant renal dysfunction (creatinine clearance <60 milliliter per minute [mL/min] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
Show all 11Show fewer
- History of solid organ or bone marrow transplantation
- Cohorts 2 and 4: Matched Healthy Participants
- History of febrile illness or other acute illness that has not fully resolved by 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
2 sites in 1 country.
United States2 sites
Division of Clinical Pharmacology, University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Oklahoma, 32809
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of VX-548 in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects
The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.
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: Mild Hepatic Impairment | Experimental | Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14. Receives: Drug: VX-548 |
| Cohort 2: Matched Healthy Participants | Experimental | Healthy participants matched to cohort 1 will receive multiple doses of VX-548 q12h from Day 1 through Day 14. Receives: Drug: VX-548 |
| Cohort 3: Moderate Hepatic Impairment | Experimental | Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14. Receives: Drug: VX-548 |
| Cohort 4: Matched Healthy Participants | Experimental | Healthy participants matched to cohort 3 will receive multiple doses of VX-548 q12h from Day 1 through Day 14. 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: Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Measured: Day 1 to Day 31
Time Taken for VX-548 to Reach Maximum Concentration (tmax)
Measured: Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2)
Measured: Day 1 to Day 31
Apparent Volume of Distribution of VX-548 (Vz/F)
Measured: Day 1 to Day 31
Apparent Clearance of VX-548 (CL/F)
Measured: Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548
Measured: Day 1 to Day 31
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite
Measured: Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 Metabolite
Measured: Day 1 to Day 31
Time Taken for VX-548 metabolite to Reach Maximum Concentration (tmax)
Measured: Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 Metabolite to Reduce to Half (t1/2)
Measured: Day 1 to Day 31
Apparent Volume of Distribution of VX-548 Metabolite (Vz/F)
Measured: Day 1 to Day 31
Apparent Clearance of VX-548 Metabolite (CL/F)
Measured: Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548 Metabolite
Measured: Day 1 to Day 31
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Measured: Day 14: Up to 24 hours Post-dose
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Measured: Day 14: Up to 24 hours Post-dose
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 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start14 Oct 2022
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05560464
- Sponsor's protocol ID
- VX21-548-007
- Status last verified
- Mar 2024
- First submitted
- 26 Sep 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 Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of VX-548 in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects
- ClinicalTrials.gov ID
- NCT05560464
- Acronym / sponsor ID
- VX21-548-007
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 29 Sep 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 pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Mild Hepatic Impairment | Experimental | Drug: VX-548Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14. |
| Cohort 2: Matched Healthy Participants | Experimental | Drug: VX-548Healthy participants matched to cohort 1 will receive multiple doses of VX-548 q12h from Day 1 through Day 14. |
| Cohort 3: Moderate Hepatic Impairment | Experimental | Drug: VX-548Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14. |
| Cohort 4: Matched Healthy Participants | Experimental | Drug: VX-548Healthy participants matched to cohort 3 will receive multiple doses of VX-548 q12h from Day 1 through Day 14. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
- Cohorts 2 and 4: Matched Healthy Participants
Key exclusion criteria (11 listed)
- Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
- Cohorts 2 and 4: Matched Healthy Participants
- 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: Mild Hepatic Impairment, Cohort 2: Matched Healthy Participants, Cohort 3: Moderate Hepatic Impairment, Cohort 4: Matched Healthy Participants |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of VX-548
Time frame: Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Time frame: Day 1 to Day 31
Time Taken for VX-548 to Reach Maximum Concentration (tmax)
Time frame: Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2)
Time frame: Day 1 to Day 31
Apparent Volume of Distribution of VX-548 (Vz/F)
Time frame: Day 1 to Day 31
Apparent Clearance of VX-548 (CL/F)
Time frame: Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548
Time frame: Day 1 to Day 31
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite
Time frame: Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 Metabolite
Time frame: Day 1 to Day 31
Time Taken for VX-548 metabolite to Reach Maximum Concentration (tmax)
Time frame: Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 Metabolite to Reduce to Half (t1/2)
Time frame: Day 1 to Day 31
Apparent Volume of Distribution of VX-548 Metabolite (Vz/F)
Time frame: Day 1 to Day 31
Apparent Clearance of VX-548 Metabolite (CL/F)
Time frame: Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548 Metabolite
Time frame: Day 1 to Day 31
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Time frame: Day 14: Up to 24 hours Post-dose
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Time frame: Day 14: Up to 24 hours Post-dose
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 42
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.
2 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 2 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 11 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 2 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 (time frame: Day 1 to Day 31). The study lists 7 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.