Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02254057
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2014-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses of 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986 BS (IV Infusion Over 30 Minutes) in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level
Status:
COMPLETED
Status Verified Date:
2014-09
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:
Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters
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?: