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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

NCT01594515 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-12-15

Study results available
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Summary

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

BI 1015550

High dose powder for oral solution

DRUG

BI 1015550

Medium dose powder for oral solution

DRUG

BI 1015550

Low dose powder for oral solution

DRUG

BI 1015550

Low dose powder for oral solution

DRUG

BI 1015550

Low dose powder for oral solution

DRUG

Placebo

Solution for oral administration

DRUG

BI 101550

High dose powder for oral solution

DRUG

BI 1015550

Low dose powder for oral solution

DRUG

BI 1015550

Medium dose powder for oral solution

DRUG

BI 1015550

Medium dose powder for oral solution

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

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 NCT01594515 on ClinicalTrials.gov