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 Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01195688

First received: September 3, 2010

Last updated: June 1, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 3, 2010

Last Updated Date

June 1, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01195688 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

healthy male subjects

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01195688

Other Study ID Numbers ^ICMJE

1279.1, 2010-021187-15

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

June 2011

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

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