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

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ClinicalTrials.gov Identifier: NCT01195688
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: BI 638683 or placebo Drug: Placebo solution Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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)
Study Start Date : September 2010
Primary Completion Date : December 2010
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion criteria:

healthy male subjects

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195688


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

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01195688     History of Changes
Other Study ID Numbers: 1279.1
2010-021187-15 ( EudraCT Number: EudraCT )
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Pharmaceutical Solutions