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Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

NCT01681277 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-01-20

Study results available
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Summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Conditions

  • Healthy

Interventions

DRUG

BI 113608 PIB bid

powder for oral solution

DRUG

Placebo to BI 113608 PIB bid

powder for oral solution

DRUG

Placebo to BI 113608 PIB bid

powder for oral solution

DRUG

Placebo to BI 113608 PIB qd

powder for oral solution

DRUG

Placebo to BI 113608 PIB bid

powder for oral solution

DRUG

BI 113608 PIB bid

powder for oral solution

DRUG

BI 113608 PIB bid

powder for oral solution

DRUG

BI 113608 PIB qd

powder for oral solution

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT01681277 on ClinicalTrials.gov