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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.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Severe Renal Impairment | Experimental | Participants will receive a single dose of VX-548 in a fasted state. |
|
| Cohort 2: Matched Healthy Participants | Experimental | Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state. |
|
| Cohort 3: Moderate Renal Impairment | Experimental | Participants will receive a single dose of VX-548 in a fasted state. |
|
| Cohort 4: Matched Healthy Participants | Experimental | Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state. |
|
| 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 and its Metabolite | 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 | Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent Clearance of VX-548 | Day 1 to Day 14 | |
| Apparent Renal Clearance of VX-548 and its Metabolite (CLr) | Day 1 to Day 14 | |
| Apparent Non-Renal Clearance of VX-548 |
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Key Inclusion Criteria:
Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
Cohorts 2 and 4: Matched Healthy Participants
Key Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infigo Clinical Research | DeLand | Florida | 32720 | United States | ||
| Clinical Pharmacology of Miami, LLC |
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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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Day 1 to Day 14 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 to Day 23 |
| Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma | Day 1 to Day 2 |
| Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite | Day 1 to Day 14 |
| Miami |
| Florida |
| 33014-3616 |
| United States |
| GCP Research | St. Petersburg | Florida | 33705 | United States |
| Genesis Clinical Research | Tampa | Florida | 33603 | United States |
| Elixia, Phase 1 Clinical Site | Tampa | Florida | 33618 | United States |
| Southwest Houston Research, Ltd | Houston | Texas | 77099 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |