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The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 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: Single Ascending Dose | Experimental | Participants will be randomized to receive a single dose of VX-407. |
|
| Placebo Part A | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-407. |
|
| Part B: Multiple Ascending Dose | Experimental | Participants will be randomized to receive multiple doses of VX-407. |
|
| Placebo Part B | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-407. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-407 | Drug | Suspension for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Enrollment up to Day 10 | |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Enrollment up to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Concentration (Cmax) of VX-407 in Plasma | From Day 1 up to Day 6 | |
| Part B: Cmax of VX-407 in Plasma | Days 1, 7, and 14 up to Day 19 | |
| Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria will 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/our-science/clinical-trials-data-sharing/
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Placebo | Drug | Suspension for oral administration. |
|
| From Day 1 up to Day 6 |
| Part B: Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-407 in Plasma | Days 1, 7, and 14 up to Day 19 |
| Part A: Time Taken for VX-407 to Reach Maximum Concentration (tmax) | From Day 1 up to Day 6 |
| Part B: Time Taken for VX-407 to Reach Maximum Concentration (tmax) | Days 1, 7, and 14 up to Day 19 |
| Part A: Renal Clearance (CLr) of VX-407 | From Day 1 up to Day 6 |
| Part B: CLr of VX-407 | Day 1 and Day 14 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |