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The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in 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 |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points. |
|
| Group 2A | Active Comparator | Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points. |
|
| Group 2B | Active Comparator | Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanzacaftor | Drug | Tablets for oral administration. |
| |
| Vanzacaftor Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QT interval corrected by Fridericia's formula (QTcF) | From Baseline up to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate (HR) | From Baseline up to Day 23 | |
| Change in PR interval, segment | From Baseline up to Day 23 | |
| 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 |
|---|---|---|---|---|---|---|
| Celerion - Tempe | Tempe | Arizona | 85283 | United States |
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 |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000731138 | deutivacaftor, tezacaftor , vanzacaftor |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Placebo for oral administration. |
|
| Moxifloxacin | Drug | Tablets for oral administration. |
|
| Moxifloxacin Placebo | Drug | Tablets for oral administration. |
|
| From Baseline up to Day 23 |
| Placebo-corrected Change in QTcF | From Baseline up to Day 23 |
| Placebo-corrected Change in HR | From Baseline up to Day 23 |
| Placebo-corrected Change in PR interval | From Baseline up to Day 23 |
| Placebo-corrected Change in QRS duration | From Baseline up to Day 23 |
| Number of Outliers for QTcF | From Baseline up to Day 23 |
| Number of Outliers for HR | From Baseline up to Day 23 |
| Number of Outliers for PR interval | From Baseline up to Day 23 |
| Number of Outliers for QRS duration | From Baseline up to Day 23 |
| Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence | From Baseline up to Day 23 |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day -2 up to Day 38 |
| Maximum Observed Plasma Concentration (Cmax) of VNZ | Days 11 and 21 |
| Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ | Days 11 and 21 |
| Time Taken for VNZ to Reach Maximum Concentration (tmax) | Days 11 and 21 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |