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).

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Healthy

Pain

Treatments

Drug: BI 660848

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01145014

2009-015995-90 (EudraCT Number)

1284.1

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

Male

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
Age 21 and 50 years
BMI 18.5 and <30 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
Evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
Intake of drugs with a long half-life (24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation
Participation in another trial with an investigational drug within 2 months prior to randomisation
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days as judged by the investigator
Alcohol abuse (more than 30 g alcohol a day)
Drug abuse
Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
Excessive physical activities within 1 week prior to randomisation or during the trial
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of the study centre

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 12 patient groups

BI 660848 2 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 10 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 20 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 50 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 100 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 150 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 200 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 400 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 600 mg

Experimental group

Description:

oral drinking solution

Treatment:

Drug: BI 660848

BI 660848 10,0 mg

Experimental group

Description:

immediate release tablet

Treatment:

Drug: BI 660848

BI 660848 50,0 mg

Experimental group

Description:

immediate release tablet

Treatment:

Drug: BI 660848

Placebo

Experimental group

Description:

matching placebo (oral drinking solution and IR tablets)

Treatment:

Drug: Placebo

Trial contacts and locations

Data sourced from clinicaltrials.gov

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