Completed

Evaluation of Safety, Tolerability, and Pharmacokinetics of BI 113608 in Healthy Male Volunteers

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Study Aim

This study aims to evaluate the safety and tolerability of BI 113608 in healthy male volunteers, focusing on the percentage of participants with drug-related adverse events and the number of participants with clinically relevant abnormalities in clinical laboratory tests, vital signs, and ECG recordings.

What is being tested

Placebo for BI 113608 PIB Study

+ BI 113608 PIB: A Twice Daily Oral Solution

+ Placebo for BI 113608 PIB Study

Drug
Who is being recruted

From 18 to 50 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorBoehringer Ingelheim
Last updated: January 20, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on a drug called BI 113608, specifically its safety and how it behaves in the body when taken in increasing doses. The participants are healthy males. The main goal is to understand how the body reacts to this drug, which could potentially lead to the development of new treatments. This research is important as it helps to determine the safety and appropriate dosage of BI 113608 before it can be tested in people with specific health conditions. During the study, participants will receive either BI 113608 or a placebo (a substance with no active medication) once or twice daily for 14 days. The study measures the number of participants who experience side effects related to the drug and the number of participants with significant abnormalities in clinical laboratory tests, vital signs, and ECG recordings. These measurements help researchers understand the safety and potential risks of BI 113608.

NCT01681277
Principal SponsorBoehringer Ingelheim
Last updated: January 20, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
1. healthy male subjects
1 exclusion criteria prevent from participating
1. Any relevant deviation from healthy conditions

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
powder in the bottle for oral solution, oral administration with 240 ml water

Group II

Experimental
powder in the bottle for oral solution, oral administration with 240 ml water

Group III

Experimental
powder in the bottle for oral solution, oral administration with 240 ml water

Group IV

Experimental
powder in the bottle for oral solution, oral administration with 240 ml water

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Boehringer Ingelheim Investigational Site

Mannheim, GermanyOpen Boehringer Ingelheim Investigational Site in Google Maps
CompletedOne Study Center