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).

Phase 1 Terminated 72 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2010-05
Primary completion: 2010-12
Completion: —

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 660848	Unknown	2 mg	Oral
Subject	BI 660848	Unknown	10 mg	Oral
Subject	BI 660848	Unknown	20 mg	Oral
Subject	BI 660848	Unknown	50 mg	Oral
Subject	BI 660848	Unknown	100 mg	Oral
Subject	BI 660848	Unknown	150 mg	Oral
Subject	BI 660848	Unknown	200 mg	Oral
Subject	BI 660848	Unknown	400 mg	Oral
Subject	BI 660848	Unknown	600 mg	Oral

Indications

No indication recorded.