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).

NCT01145014 | Terminated Phase 1

• 2 other identifiers: 1284.12009-015995-90
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Healthy

Outcome Measures

Primary Outcomes (6)

• Safety and tolerability (number and intensity of adverse events).

  4 months

• Changes in blood pressure.

  4 months

• Changes in pulse rate.

  4 months

• Changes in respiratory rate.

  4 months

• Changes in 12-lead ECG.

  4 months

• Changes in clinical laboratory test parameters.

  4 months

Secondary Outcomes (10)

• Cmax (maximum measured concentration of the analyte in plasma)

  3 days

• tmax (time from dosing to maximum measured concentration)

  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

Study Arms (12)

BI 660848 2 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 10 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 20 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 50 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 100 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 150 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 200 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 400 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 600 mg

EXPERIMENTAL

oral drinking solution

Drug: BI 660848

BI 660848 10,0 mg

EXPERIMENTAL

immediate release tablet

Drug: BI 660848

BI 660848 50,0 mg

EXPERIMENTAL

immediate release tablet

Drug: BI 660848

Placebo

EXPERIMENTAL

matching placebo (oral drinking solution and IR tablets)

Drug: Placebo

Interventions

BI 660848 DRUG

2 mg oral drinking solution

BI 660848 2 mg

Placebo DRUG

matching placebo (oral drinking solution and IR tablets)

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1284.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: June 16, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (1)