Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT01473069
Status:
TERMINATED
Last Update Posted:
2011-11-21
First Post:
2011-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects
Sponsor:
Akros Pharma Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of JTK-853 Administered for Two Weeks in Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2011-11
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 was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).
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?: