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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).

NCT ID: NCT01145014

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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

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Conditions

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Pain Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 660848 2 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

2 mg oral drinking solution

BI 660848 10 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

10 mg oral drinking solution

BI 660848 20 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

20 mg oral drinking solution

BI 660848 50 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

50 mg oral drinking solution

BI 660848 100 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

100 mg oral drinking solution

BI 660848 150 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

150 mg oral drinking solution

BI 660848 200 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

200 mg oral drinking solution

BI 660848 400 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

400 mg oral drinking solution

BI 660848 600 mg

oral drinking solution

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

600 mg oral drinking solution

BI 660848 10,0 mg

immediate release tablet

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

10,0 mg immediate release tablet

BI 660848 50,0 mg

immediate release tablet

Group Type EXPERIMENTAL

BI 660848

Intervention Type DRUG

50,0 mg immediate release tablet

Placebo

matching placebo (oral drinking solution and IR tablets)

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

matching placebo (oral drinking solution and IR tablets)

Interventions

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BI 660848

2 mg oral drinking solution

Intervention Type DRUG

BI 660848

10 mg oral drinking solution

Intervention Type DRUG

BI 660848

20 mg oral drinking solution

Intervention Type DRUG

BI 660848

50 mg oral drinking solution

Intervention Type DRUG

BI 660848

100 mg oral drinking solution

Intervention Type DRUG

BI 660848

150 mg oral drinking solution

Intervention Type DRUG

BI 660848

200 mg oral drinking solution

Intervention Type DRUG

BI 660848

400 mg oral drinking solution

Intervention Type DRUG

BI 660848

600 mg oral drinking solution

Intervention Type DRUG

BI 660848

10,0 mg immediate release tablet

Intervention Type DRUG

BI 660848

50,0 mg immediate release tablet

Intervention Type DRUG

Placebo

matching placebo (oral drinking solution and IR tablets)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Age 21 and 50 years
3. BMI 18.5 and \<30 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
2. Evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
8. 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
9. 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
10. Participation in another trial with an investigational drug within 2 months prior to randomisation
11. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
12. Inability to refrain from smoking on trial days as judged by the investigator
13. Alcohol abuse (more than 30 g alcohol a day)
14. Drug abuse
15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
16. Excessive physical activities within 1 week prior to randomisation or during the trial
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of the study centre
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1284.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-015995-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1284.1

Identifier Type: -

Identifier Source: org_study_id