Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-29 @ 11:42 PM
Study NCT ID:
NCT01291732
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2011-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)
Status:
COMPLETED
Status Verified Date:
2013-10
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:
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: