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

• Conditions: Healthy; Pain
• Interventions: Drug: BI 660848; Drug: Placebo

• Registration Number: NCT01145014
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Primary Completion: 2010-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 660848 2 mg	BI 660848	oral drinking solution
BI 660848 10 mg	BI 660848	oral drinking solution
BI 660848 20 mg	BI 660848	oral drinking solution
BI 660848 50 mg	BI 660848	oral drinking solution
BI 660848 100 mg	BI 660848	oral drinking solution
BI 660848 150 mg	BI 660848	oral drinking solution
BI 660848 50,0 mg	BI 660848	immediate release tablet
Placebo	Placebo	matching placebo (oral drinking solution and IR tablets)
BI 660848 200 mg	BI 660848	oral drinking solution
BI 660848 400 mg	BI 660848	oral drinking solution
BI 660848 600 mg	BI 660848	oral drinking solution
BI 660848 10,0 mg	BI 660848	immediate release tablet

Primary Outcome Measures

Name	Time	Method
Changes in blood pressure.	4 months
Changes in pulse rate.	4 months
Safety and tolerability (number and intensity of adverse events).	4 months
Changes in 12-lead ECG.	4 months
Changes in respiratory rate.	4 months
Changes in clinical laboratory test parameters.	4 months

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	3 days
CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)	3 days
tmax (time from dosing to maximum measured concentration)	3 days
Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)	3 days
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)	3 days
AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	3 days
t1/2 (terminal half-life of the analyte in plasma)	3 days
MRT (mean residence time of the analyte in the body after drug intake)	3 days
CL/F (apparent clearance of the analyte in plasma after extravascular administration)	3 days
fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2)	3 days

Trial Locations

Locations (1)

1284.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany