NCT06154447
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
Completed
PHASE1Ages 18+InterventionalTreatmentVertex Pharmaceuticals Incorporated
~165 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:VX-828PlaceboItraconazoleMidazolamTezacaftorVX-118
At a glance
Recruiting sites
0 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 67)
+7 more outcomes measured
Conditions
Where it's being run
12 sites across 11 statesFlorida2
Kansas1
Kentucky1
Massachusetts1
Minnesota1
Montana1
New York1
Ohio1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants between the ages of 18 and 55 years
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
Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
Cohort C2 only: Willing to provide a single DNA sample
Participants 18 years or older
Confirmed diagnosis of CF as determined by the investigator
A total body weight of more than or equal to (\>=) 35 kg
Participants must be heterozygous for F508del with a second CFTR allele carrying a minimal function mutation that is not responsive to ELX/TEZ/IVA therapy
Participants must have a forced expiratory volume in 1 second (FEV1) of greater than or equal to (≥) 40% of predicted normal for age, sex, and height
Exclusion
History of febrile illness or other acute illness within 14 days before the first dose of study drug
Any condition possibly affecting drug absorption
An acute illness not related to CF (e.g., gastroenteritis) within 14 days before the first dose of study drug
History of solid organ or hematological transplantation
History of clinically significant cirrhosis with or without portal hypertension
Lung infection with organisms associated with a more rapid decline in pulmonary status
What this trial measures
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 67)
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)
- Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)
- Part E: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Signing of Informed Consent Form (ICF) up to End of Study (Up to Day 111)
- Part C: Maximum Observed Concentration (Cmax) of VX-828 in Plasma in the Absence and Presence of ItraconazoleFrom Day 1 up to Day 71
- Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-828 in Plasma in the Absence and Presence of ItraconazoleFrom Day 1 up to Day 71
- Part C: Maximum Observed Concentration (Cmax) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVAFrom Day 1 up to Day 30
- Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Plasma in the Absence and Presence of VX-828/TEZ/D-IVAFrom Day 1 up to Day 30