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

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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 638683 or placebo; Drug: Placebo solution

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1279.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

healthy male subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): June 2, 2011
• Last Update Submitted That Met QC Criteria: June 1, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 1279.1; 2010-021187-15 (EudraCT Number: EudraCT)