Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01195688
First received: September 3, 2010
Last updated: June 1, 2011
Last verified: June 2011

September 3, 2010
June 1, 2011
September 2010
December 2010   (final data collection date for primary outcome measure)
  • Safety of BI 638683 will be assessed in a descriptive way. [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
  • Tolerability of BI 638683 will be assessed in a descriptive way. [ Time Frame: up to 14 days post treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01195688 on ClinicalTrials.gov Archive Site
  • To assess pharmacodynamics of BI 638683. [ Time Frame: up to 5 days post study drug administration ] [ Designated as safety issue: No ]
  • To assess pharmacokinetics of BI 638683. [ Time Frame: up to 5 days post study drug administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
  • Drug: BI 638683 or placebo
    oral doses given to 6 subjects per dose group
  • Drug: Placebo solution
    oral doses given to 2 subjects per dose group
  • Experimental: BI 638683
    1 single dose per subject as oral solution
    Intervention: Drug: BI 638683 or placebo
  • Placebo Comparator: Placebo solution
    1 single dose per subject as oral solution
    Intervention: Drug: Placebo solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
Not Provided
December 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

healthy male subjects

Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01195688
1279.1, 2010-021187-15
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP