Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.

Summary

The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.

The primary objective is to investigate the safety and tolerability of treatment with BI 661051.

The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal.

Pharmacodynamic parameters will not be determined within this study.

Conditions

• Healthy

Interventions

DRUG

BI 661051

medium dose solution for oral administration

DRUG

BI 661051

medium dose solution for oral administration

DRUG

BI 661051

medium dose solution for oral administration

DRUG

BI 661051

low dose solution for oral administration

DRUG

BI 661051

low dose solution for oral administration

DRUG

BI 661051

low dose solution for oral administration

DRUG

BI 661051

high dose solution for oral administration

DRUG

BI 661051

high dose solution for oral administration

DRUG

BI 661051

low dose tablet

DRUG

Placebo

solution for administration

DRUG

BI 661051

medium dose tablet

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2011-07-31

Countries

• Germany

Study Locations