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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers

NCT02057835 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-12-16

Study results available
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Summary

BI 691751 is currently being developed to inhibit growth and prevent rupture of atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and Japanese male volunteers.

Conditions

  • Healthy

Interventions

DRUG

Placebo to BI 691751

Placebo to BI 691751

DRUG

BI 691751 high dose

BI 691751 high dose

DRUG

BI 691751 middle dose

BI 691751 middle dose

DRUG

Placebo to BI 691751

Placebo to BI 691751

DRUG

BI 691751 low dose 1

BI 691751 low dose 1

DRUG

Placebo to BI 691751

Placebo to BI 691751

DRUG

Placebo to BI 691751

Placebo to BI 691751

DRUG

BI 691751 low dose 2

BI 691751 low dose 2

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
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • South Korea

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 NCT02057835 on ClinicalTrials.gov