Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299709
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2024-02-29
Brief Title:
A Study To Evaluate the Relative Bioavailability Food Effect and Dose Proportionality of a Granule Formulation of VanzacaftorTezacaftorDeutivacaftorVNZTEZD-IVA
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Vertex Pharmaceuticals Incorporated
Study Overview
Official Title:
A Phase 1 Randomized Open-Label 2-part Study to Evaluate the Relative Bioavailability Food Effect and Dose Proportionality of a Granule Formulation of Vanzacaftor in Combination With Tezacaftor and Deutivacaftor in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the relative bioavailability food effect and dose proportionality of a granule formulation of VNZTEZD-IVA
Detailed Description:
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 402j4A of the Public Health Service Act and 42 CFR 1160 and is not subject to the deadlines established by sections 402j2 and 3 of the Public Health Service Act or 42 CFR 1124 and 1144
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None