We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195688
First Posted: September 6, 2010
Last Update Posted: June 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  Purpose
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
Healthy Drug: BI 638683 or placebo Drug: Placebo solution Phase 1

Study Type: Interventional
Study Design: 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)

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 3, 2010
First Posted: September 6, 2010
Last Update Posted: June 2, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Pharmaceutical Solutions