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The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 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 |
|---|---|---|---|
| Part A: VX-840 | Experimental | Participants will be randomized to receive single dose of one of different dose levels of VX-840. |
|
| Part A: Placebo | Placebo Comparator | Participants will receive placebo matched to VX-840. |
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| Part B: VX-840 | Experimental | Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A. |
|
| Part B: Placebo | Placebo Comparator | Participants will receive placebo matched to VX-840. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-840 | Drug | Solution for oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Plasma Concentration of VX-840 Over Time | From Day 1 up to Day 14 | |
| Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)] | From Day 1 up to Day 14 |
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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 |
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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| Placebo |
| Drug |
Placebo matched to VX-840 for oral administration. |
|
| Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)] | From Day 1 up to Day 14 |
| Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae) | From Day 1 up to Day 14 |
| Part B: Associated Renal Clearance (CLr) of VX-840 | From Day 1 up to Day 14 |