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First in Man Trial of BI 113608

NCT01540825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-01-20

Study results available
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Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Conditions

  • Healthy

Interventions

DRUG

BI 113608

Low dose powder for oral solution

DRUG

BI 113608

High dose powder for oral solution

DRUG

BI 113608

Medium dose powder for oral solution

DRUG

BI 113608

Low dose powder for oral solution

DRUG

Placebo

Powder for oral solution

DRUG

BI 113608

Low dose powder for oral solution

DRUG

BI 113608

High dose powder for oral solution

DRUG

BI 113608

High dose powder for oral solution

DRUG

BI 113608

Medium dose powder for oral solution

DRUG

BI 113608

Medium dose powder for oral solution

DRUG

BI 113608

Low dose powder for oral solution

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540825 on ClinicalTrials.gov