Safety of Single Rising Doses and Relative Bioavailability of BI 691751

NCT01843972 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-06-27

Study results available
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Summary

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Conditions

  • Healthy

Interventions

DRUG

BI 691751

oral solution BI 691751, dose 6

DRUG

BI 691751

oral solution

DRUG

Placebo

placebo solution

DRUG

BI 691751

oral solution BI 691751, dose 2

DRUG

BI 691751

oral solution BI 691751, dose 5

DRUG

BI 691751

1 tablet

DRUG

BI 691751

oral solution BI 691751, dose 3

DRUG

BI 691751

oral solution BI 69175, dose 4

DRUG

BI 691751

oral solution BI 691751, dose 7

DRUG

BI 691751

oral solution BI 69175, dose 1

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT01843972 on ClinicalTrials.gov