Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-28 @ 12:11 PM
Study NCT ID:
NCT00417261
Status:
COMPLETED
Last Update Posted:
2008-06-23
First Post:
2006-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.
Sponsor:
Novartis
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Ascending Single and Multiple Dose, Seamless Design Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Orally Administered Compounds, ATF936 and AXT914, in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2008-06
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:
This is a first-in-human study and is designed to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic effects of a single and multiple-doses of ATF936 and AXT914 administered orally in healthy subjects.
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?: