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The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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-973 under fasted conditions. |
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| Part B: Multiple Ascending Dose | Experimental | Participants will be randomized to receive multiple doses of VX-973 under fasted conditions. |
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| Placebo Part A | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-973. |
|
| Placebo Part B | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-973. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-973 | 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 Day -1 up to Day 30 | |
| Part 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 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973 | From Day 1 up to Day 30 | |
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973 | From Day 1 up to Day 85 | |
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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 Salt Lake City | Salt Lake City | Utah | 84124 | 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 |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Suspension for oral administration. |
|
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973 |
| From Day 1 up to Day 30 |
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973 | From Day 1 up to Day 85 |
| Part A: Time Taken for VX-973 to Reach Maximum Concentration (tmax) | From Day 1 up to Day 30 |
| Part B: Time Taken for VX-973 to Reach Maximum Concentration (tmax) | From Day 1 up to Day 85 |
| Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test | From Day 1 up to Day 53 |