Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis
A Phase 1 Study of VX-581 in Healthy Subjects and in Subjects With Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA in healthy participants. The study will also evaluate the safety, tolerability, and pharmacokinetics of VX-581 administered in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study is being conducted to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581 in healthy participants and in participants with CF. VX-581 will be administered alone and in combination with TEZ and D-IVA. The study consists of Screening Phase, Run-In Phase (CF only), Treatment Phase and Safety Follow-up Phase.
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
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Medical Information
- Telefonnummer: 617-341-6777
- E-post: medicalinfo@vrtx.com
Studiesteder
-
-
Kansas
-
Overland Park, Kansas, Forente stater, 66212
- Rekruttering
- Altasciences - Kansas City
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
-
Parts A, B, C:
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- A total body weight of more than (>) 50 kg
-
Part D:
- Confirmed diagnosis of CF
Key Exclusion Criteria:
-
Parts A, B, C:
- 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
-
Part D:
- History of clinically significant cirrhosis with or without portal hypertension.
Other protocol defined Inclusion/Exclusion criteria may apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-581. |
Suspension for Oral Administration. Tablets for Oral Administration. |
|
Placebo komparator: Placebo: Part A
Participants will be randomized to receive a single dose of placebo matched to VX-581. |
Suspension for Oral Administration. |
|
Eksperimentell: Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-581. |
Suspension for Oral Administration. Tablets for Oral Administration. |
|
Placebo komparator: Placebo: Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-581. |
Suspension for Oral Administration. |
|
Eksperimentell: Part C: VX-581 with TEZ/D-IVA or D-IVA
Participants will be randomized to receive multiple doses VX-581 in combination with TEZ/D-IVA or D-IVA. |
Suspension for Oral Administration. Tablets for Oral Administration. Tablet for Oral Administration.
Andre navn:
Tablet for Oral Administration.
Andre navn:
|
|
Placebo komparator: Placebo: Part C
Participants will be randomized to receive placebo matched to VX-581 in combination with TEZ/D-IVA or D-IVA. |
Suspension for Oral Administration. Tablet for Oral Administration.
Andre navn:
Tablet for Oral Administration.
Andre navn:
|
|
Eksperimentell: Part D: VX-581 with TEZ/D-IVA or D-IVA in CF
Participants with CF will enter a run-in period and receive ELX/TEZ/IVA. Following the run-in period participants will receive VX-581 in combination with TEZ/D-IVA or D-IVA in the treatment period. Following the treatment period, participants will enter a 14-day Washout Period and receive ELX/TEZ/IVA. (Part D will be open-label) |
Suspension for Oral Administration. Tablets for Oral Administration. Tablet for Oral Administration.
Andre navn:
Tablet for Oral Administration.
Andre navn:
Fixed dose combination (FDC) Tablets for Oral Administration.
Andre navn:
Tablet for Oral Administration.
Andre navn:
|
Hva måler studien?
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 8
|
From Day -1 up to Day 8
|
|
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 17
|
From Day -1 up to Day 17
|
|
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 17
|
From Day -1 up to Day 17
|
|
Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Signing of Informed Consent up to Day 105
|
From Signing of Informed Consent up to Day 105
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581
Tidsramme: On Day 1
|
On Day 1
|
|
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post-Dose of VX-581
Tidsramme: On Day 1
|
On Day 1
|
|
Part B: Cmax of VX-581
Tidsramme: On Days 1, 7, and 10
|
On Days 1, 7, and 10
|
|
Part B: AUC0-24h Post-Dose of VX-581
Tidsramme: On Days 1, 7, and 10
|
On Days 1, 7, and 10
|
|
Part C: Cmax of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Tidsramme: On Days 1, 7, and 10
|
On Days 1, 7, and 10
|
|
Part C: AUC0-24h Post Dose of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Tidsramme: On Days 1, 7, and 10
|
On Days 1, 7, and 10
|
|
Part D: Cmax of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Tidsramme: On Day 1 and Day 28
|
On Day 1 and Day 28
|
|
Part D: AUC0-24h Post Dose of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Tidsramme: On Day 1 and Day 28
|
On Day 1 and Day 28
|
|
Part D: Absolute Change in Sweat Chloride (SwCl)
Tidsramme: From Baseline Up To Day 28
|
From Baseline Up To Day 28
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Genetiske sykdommer, medfødte
- Sykdommer i luftveiene
- Sykdommer i fordøyelsessystemet
- Lungesykdommer
- Spedbarn, nyfødte, sykdommer
- Pankreassykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Cystisk fibrose
- Elexacaftor, Ivacaftor, Tezacaftor Drug Combination
- Tezacaftor
- ivacaftor
- Deutivacaftor, Tezacaftor, Vanzacaftor
Andre studie-ID-numre
- VX25-581-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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/
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