Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-25 @ 6:34 PM
Study NCT ID:
NCT02561650
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2015-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic, Bioavailability, and Safety Study of COV155 Administered in Healthy Subjects Under Fed and Fasted Conditions
Sponsor:
Mallinckrodt
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Pharmacokinetics, Bioavailability, and Safety of COV155 Administered in Normal, Healthy Subjects Under Fed (High- and Low-Fat Meal) and Fasted Conditions
Status:
COMPLETED
Status Verified Date:
2016-10
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:
A single center, single dose, open-label, randomized, 3-period, 6-sequence, crossover study conducted in normal healthy subjects to evaluate the effect of a high- and low-fat meal on the pharmacokinetics (PK), bioavailability (BA), and safety of COV155.
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?: