Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270511
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-02-13
Brief Title:
A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants
Sponsor:
Shionogi
Organization:
Shionogi Inc
Study Overview
Official Title:
A Phase 1 2-Part Study to Evaluate the Relative Bioavailability of and Food-Effect on Pharmacokinetics of Different Formulations of S-337395 and to Assess the Safety Tolerability and Pharmacokinetics Following Multiple Doses of S-337395 in Healthy Adult Participants
Status:
COMPLETED
Status Verified Date:
2024-07
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 aim of this study is to investigate different formulations of S-337395
Detailed Description:
This single-center study comprises an open-label randomized crossover study and a double-blinded placebo-controlled randomized multiple-dose study to examine the relative bioavailability food effect pharmacokinetics safety and tolerability of different formulations of S-337395
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