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

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

Condition Intervention Phase
Drug: BI 638683 or placebo
Drug: Placebo solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Safety of BI 638683 will be assessed in a descriptive way. [ Time Frame: up to 14 days post treatment ]
  • Tolerability of BI 638683 will be assessed in a descriptive way. [ Time Frame: up to 14 days post treatment ]

Secondary Outcome Measures:
  • To assess pharmacodynamics of BI 638683. [ Time Frame: up to 5 days post study drug administration ]
  • To assess pharmacokinetics of BI 638683. [ Time Frame: up to 5 days post study drug administration ]

Enrollment: 63
Study Start Date: September 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 638683
1 single dose per subject as oral solution
Drug: BI 638683 or placebo
oral doses given to 6 subjects per dose group
Placebo Comparator: Placebo solution
1 single dose per subject as oral solution
Drug: Placebo solution
oral doses given to 2 subjects per dose group


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

healthy male subjects

  Contacts and Locations
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Please refer to this study by its identifier: NCT01195688

1279.1.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT01195688     History of Changes
Other Study ID Numbers: 1279.1
2010-021187-15 ( EudraCT Number: EudraCT )
Study First Received: September 3, 2010
Last Updated: June 1, 2011

Additional relevant MeSH terms:
Pharmaceutical Solutions processed this record on May 25, 2017