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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 638683 or placebo; Drug: Placebo solution

• Registration Number: NCT01195688
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Primary Completion: 2010-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 638683	BI 638683 or placebo	1 single dose per subject as oral solution
Placebo solution	Placebo solution	1 single dose per subject as oral solution

Primary Outcome Measures

Name	Time	Method
Safety of BI 638683 will be assessed in a descriptive way.	up to 14 days post treatment
Tolerability of BI 638683 will be assessed in a descriptive way.	up to 14 days post treatment

Secondary Outcome Measures

Name	Time	Method
To assess pharmacodynamics of BI 638683.	up to 5 days post study drug administration
To assess pharmacokinetics of BI 638683.	up to 5 days post study drug administration

Trial Locations

Locations (1)

1279.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany