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The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.
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 |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. |
|
| Group 2A | Active Comparator | Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. |
|
| Group 2B | Active Comparator | Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-548 | Drug | Tablets for oral administration. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in QT interval corrected by Fridericia's formula (QTcF) | From Baseline up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate (HR) | From Baseline up to Day 12 | |
| Change in PR interval, segment | From Baseline up to Day 12 | |
| Change in QRS duration |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Lenexa | Lenexa | Kansas | 66219 | United States | ||
| ICON Salt Lake City |
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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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Capsules for oral administration. |
|
| Moxifloxacin Placebo | Drug | Capsules for oral administration. |
|
| VX-548 Placebo | Drug | Tablets for oral administration. |
|
| From Baseline up to Day 12 |
| Placebo-corrected Change in QTcF | From Baseline up to Day 12 |
| Placebo-corrected Change in HR | From Baseline up to Day 12 |
| Placebo-corrected Change in PR interval | From Baseline up to Day 12 |
| Placebo-corrected Change in QRS duration | From Baseline up to Day 12 |
| Number of Outliers for QTcF | From Baseline up to Day 12 |
| Number of Outliers for HR | From Baseline up to Day 12 |
| Number of Outliers for PR interval | From Baseline up to Day 12 |
| Number of Outliers for QRS duration | From Baseline up to Day 12 |
| Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence | From Baseline up to Day 12 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 26 |
| Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite | Days 6 and 10: Pre-dose up to 24 hours |
| Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite | Days 6 and 10: Pre-dose up to 24 hours |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |