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
  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
Endpoint Classification: Safety Study
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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

healthy male subjects

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01195688     History of Changes
Other Study ID Numbers: 1279.1, 2010-021187-15
Study First Received: September 3, 2010
Last Updated: June 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014