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Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects

NCT02148107 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-02-29

Study results available
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Summary

It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.

Conditions

  • Healthy

Interventions

DRUG

BI 691751

BI 691751 Dose 1

DRUG

BI 691751

BI 691751 Dose 2

DRUG

BI 691751

BI 691751 Dose 3

DRUG

BI 691751

BI 691751 Dose 4

DRUG

BI 691751

BI 691751 Dose 5

DRUG

BI 691751

BI 691751 Dose 6

DRUG

Placebo

Placebo

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
2014-05-31
Primary Completion
2014-07-31
Completion
2014-08-31

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 NCT02148107 on ClinicalTrials.gov