VX-828
DrugSuspension for Oral Administration
NCT Number: NCT06154447
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center, Hollywood, Florida, United States
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.).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Parts A-D:
Part E:
Key Exclusion Criteria:
Parts A-D:
Part E:
Other protocol defined Inclusion/Exclusion criteria will apply.
Suspension for Oral Administration
Suspension for Oral Administration
Solution for Oral Administration
Syrup for Oral Administration
Tablets for Oral Administration
Other names: TEZ, VX-661
Tablets for Oral Administration
Tablets for Oral Administration
Other names: D-IVA, VX-561
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 67)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 80)
Time frame: From Signing of Informed Consent Form (ICF) up to End of Study (Up to Day 111)
Time frame: From Day 1 up to Day 71
Time frame: From Day 1 up to Day 71
Time frame: From Day 1 up to Day 30
Time frame: From Day 1 up to Day 30
Time frame: From Day 1 up to Day 67
Time frame: From Day 1 up to Day 67
Time frame: From Day 1 up to Day 80
Time frame: From Day 1 up to Day 80
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 82)
Time frame: Day 28
Time frame: Day 28
Time frame: Day 1 and Day 28
Time frame: Day 28
Time frame: Pre-dose at Day 4, Day 8, Day 15, Day 22, Day 35, Day 49, Day 63, Day 80
Time frame: From Baseline and At Day 28
Vertex Pharmaceuticals Incorporated
Industry
A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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