Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Mild Hepatic Impairment | Experimental | Participants will receive multiple doses of VX-548 every 12 hours (q12h) from Day 1 through Day 14. |
|
| 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. |
|
| Cohort 3: Moderate Hepatic Impairment | Experimental | Participants will receive multiple doses of VX-548 q12h from Day 1 through Day 14. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-548 | Drug | Tablets for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of VX-548 | Day 1 to Day 31 | |
| Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 | Day 1 to Day 31 | |
| Time Taken for VX-548 to Reach Maximum Concentration (tmax) | Day 1 to Day 31 | |
| Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2) | Day 1 to Day 31 | |
| Apparent Volume of Distribution of VX-548 (Vz/F) | Day 1 to Day 31 | |
| Apparent Clearance of VX-548 (CL/F) | 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 | Day 1 to Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite | Day 1 to Day 31 | |
| Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 Metabolite | Day 1 to Day 31 |
Not provided
Key Inclusion Criteria:
Cohorts 1 and 3: Participants with Mild or Moderate Hepatic Impairment
Cohorts 2 and 4: Matched Healthy Participants
Key Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Clinical Pharmacology, University of Miami | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center |
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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Time Taken for VX-548 metabolite to Reach Maximum Concentration (tmax) | Day 1 to Day 31 |
| Time Required for Plasma Concentration of VX-548 Metabolite to Reduce to Half (t1/2) | Day 1 to Day 31 |
| Apparent Volume of Distribution of VX-548 Metabolite (Vz/F) | Day 1 to Day 31 |
| Apparent Clearance of VX-548 Metabolite (CL/F) | 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 | Day 1 to Day 31 |
| Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma | Day 14: Up to 24 hours Post-dose |
| Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite | 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) | From Day 1 up to Day 42 |
| Orlando |
| Oklahoma |
| 32809 |
| United States |