A Phase 1, First-in-human Study of VX-433
4. juni 2026 opdateret af: Vertex Pharmaceuticals Incorporated
A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
118
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Medical Information
- Telefonnummer: 617-341-6777
- E-mail: medicalinfo@vrtx.com
Studiesteder
-
-
Utah
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Salt Lake City, Utah, Forenede Stater, 84124
- Rekruttering
- ICON - Utah - Salt Lake City Office
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Key Inclusion Criteria:
- Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m2), inclusive
- A total body weight of more than (>) 50 kg
- Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
Key Exclusion Criteria:
- History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption
- For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug
Other protocol defined Inclusion/Exclusion criteria will apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of VX-433.
|
Suspension for Oral Administration
|
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Placebo komparator: Part A: Placebo
Participants will be randomized to receive placebo matched to VX-433.
|
Suspension for oral administration
|
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Eksperimentel: Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of VX-433.
|
Suspension for Oral Administration
|
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Placebo komparator: Part B: Placebo
Participants will be randomized to receive placebo matched to VX-433.
|
Suspension for oral administration
|
|
Eksperimentel: Part C: Drug Drug Interaction
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. |
Sirup til oral administration
Suspension for Oral Administration
Capsule for Oral Administration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to Day 6
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From Day 1 up to Day 6
|
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Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to Day 18
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From Day 1 up to Day 18
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Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433
Tidsramme: From Day 1 up to Day 22
|
From Day 1 up to Day 22
|
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Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433
Tidsramme: From Day 1 up to Day 22
|
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
Tidsramme: From Day 1 up to Day 22
|
From Day 1 up to Day 22
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Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433
Tidsramme: From Day 1 up to Day 22
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From Day 1 up to Day 22
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433
Tidsramme: From Day 1 up to Day 6
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From Day 1 up to Day 6
|
|
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433
Tidsramme: From Day 1 up to Day 18
|
From Day 1 up to Day 18
|
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Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433
Tidsramme: From Day 1 up to Day 6
|
From Day 1 up to Day 6
|
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Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433
Tidsramme: From Day 1 up to Day 18
|
From Day 1 up to Day 18
|
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Part A: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2)
Tidsramme: From Day 1 up to Day 6
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From Day 1 up to Day 6
|
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Part B: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2)
Tidsramme: From Day 1 up to Day 18
|
From Day 1 up to Day 18
|
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Part A: Renal Clearance (CLr) of VX-433
Tidsramme: From Day 1 up to Day 2
|
From Day 1 up to Day 2
|
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Part B: Renal Clearance (CLr) of VX-433
Tidsramme: From Day 1 up to Day 11
|
From Day 1 up to Day 11
|
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Part A: Amount of VX-433 excreted in Urine
Tidsramme: From Day 1 up to Day 2
|
From Day 1 up to Day 2
|
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Part B: Amount of VX-433 excreted in Urine
Tidsramme: From Day 1 up to Day 11
|
From Day 1 up to Day 11
|
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Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to Day 29
|
From Day 1 up to Day 29
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. maj 2026
Primær færdiggørelse (Anslået)
5. marts 2027
Studieafslutning (Anslået)
5. marts 2027
Datoer for studieregistrering
Først indsendt
6. maj 2026
Først indsendt, der opfyldte QC-kriterier
6. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VX25-433-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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/
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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