A Phase 1, First-in-human Study of VX-433
4. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.).
Studietype
Intervensjonell
Registrering (Antatt)
118
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Medical Information
- Telefonnummer: 617-341-6777
- E-post: medicalinfo@vrtx.com
Studiesteder
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Utah
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Salt Lake City, Utah, Forente stater, 84124
- Rekruttering
- ICON - Utah - Salt Lake City Office
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of VX-433.
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Suspension for Oral Administration
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Placebo komparator: Part A: Placebo
Participants will be randomized to receive placebo matched to VX-433.
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Suspensjon for oral administrasjon
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Eksperimentell: Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of VX-433.
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Suspension for Oral Administration
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Placebo komparator: Part B: Placebo
Participants will be randomized to receive placebo matched to VX-433.
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Suspensjon for oral administrasjon
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Eksperimentell: 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 for oral administrering
Suspension for Oral Administration
Capsule for Oral Administration
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
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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
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From Day 1 up to Day 22
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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
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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
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
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Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433
Tidsramme: From Day 1 up to Day 18
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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
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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
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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
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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
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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
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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
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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
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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
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From Day 1 up to Day 29
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. mai 2026
Primær fullføring (Antatt)
5. mars 2027
Studiet fullført (Antatt)
5. mars 2027
Datoer for studieregistrering
Først innsendt
6. mai 2026
Først innsendt som oppfylte QC-kriteriene
6. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juni 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VX25-433-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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/
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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