To Investigate Safety, Tolerability, and Pharmacokinetics of Treatment With BI 660848 Rising Single Doses (From 2 mg to 600 mg) Administered as Oral Drinking Solution (Powder in Bottle).

Summary

As a transition from preclinical investigations to clinical development in this first-in-human trial, safety, tolerability, and pharmacokinetics of BI 660848 will be assessed in human male volunteers using single rising oral doses in order to provide the basis for a potential ongoing clinical development of BI 660848 in the indication of neuropathic pain.

Conditions

• Pain
• Healthy

Interventions

DRUG

BI 660848

2 mg oral drinking solution

DRUG

BI 660848

10 mg oral drinking solution

DRUG

BI 660848

20 mg oral drinking solution

DRUG

BI 660848

50 mg oral drinking solution

DRUG

BI 660848

100 mg oral drinking solution

DRUG

BI 660848

150 mg oral drinking solution

DRUG

BI 660848

200 mg oral drinking solution

DRUG

BI 660848

400 mg oral drinking solution

DRUG

BI 660848

600 mg oral drinking solution

DRUG

BI 660848

10,0 mg immediate release tablet

DRUG

BI 660848

50,0 mg immediate release tablet

DRUG

Placebo

matching placebo (oral drinking solution and IR tablets)

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2010-12-31

Countries

• Germany

Study Locations