Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-01 @ 2:46 AM
Study NCT ID:
NCT01899105
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2013-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
Sponsor:
Vertex Pharmaceuticals Incorporated
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: