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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.
The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C).
Note: 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 (SAD) | Experimental | Participants will be randomized to receive a single dose of VX-433. |
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| Part A: Placebo | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-433. |
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| Part B: Multiple Ascending Dose (MAD) | Experimental | Participants will be randomized to receive multiple doses of VX-433. |
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| Part B: Placebo | Placebo Comparator | Participants will be randomized to receive placebo matched to VX-433. |
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| Part C: Drug Drug Interaction | Experimental | Participants will receive a single dose of midazolam and bupropion on Day 1 in Dosing Period 1, followed by VX-433 administration for 17 days (Days 5 through 21) and then midazolam and bupropion on Day 18 in Dosing Period 2. Part C will be open-label. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-433 | 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 6 | |
| 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 18 | |
| Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433 | From Day 1 up to Day 22 | |
| Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433 | From Day 1 up to Day 22 | |
| Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-433 | From Day 1 up to Day 22 | |
| Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433 | From Day 1 up to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433 | From Day 1 up to Day 6 | |
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433 | From Day 1 up to Day 18 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria will apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 617-341-6777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON - Utah - Salt Lake City Office | Recruiting | 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/our-science/clinical-trials-data-sharing/
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Suspension for Oral Administration |
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| Midazolam | Drug | Syrup for Oral Administration |
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| Bupropion | Drug | Capsule for Oral Administration |
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| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433 |
| From Day 1 up to Day 6 |
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433 | From Day 1 up to Day 18 |
| Part A: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2) | From Day 1 up to Day 6 |
| Part B: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2) | From Day 1 up to Day 18 |
| Part A: Renal Clearance (CLr) of VX-433 | From Day 1 up to Day 2 |
| Part B: Renal Clearance (CLr) of VX-433 | From Day 1 up to Day 11 |
| Part A: Amount of VX-433 excreted in Urine | From Day 1 up to Day 2 |
| Part B: Amount of VX-433 excreted in Urine | From Day 1 up to Day 11 |
| Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 29 |
| D006571 | Heterocyclic Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |