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).

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01145014
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Healthy	Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: BI 660848; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I - Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses 2 mg to 600 mg of BI 660848 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of an Immediate Release Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle).
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 660848 2 mg oral drinking solution	Drug: BI 660848; 2 mg oral drinking solution
Experimental: BI 660848 10 mg oral drinking solution	Drug: BI 660848; 10 mg oral drinking solution
Experimental: BI 660848 20 mg oral drinking solution	Drug: BI 660848; 20 mg oral drinking solution
Experimental: BI 660848 50 mg oral drinking solution	Drug: BI 660848; 50 mg oral drinking solution
Experimental: BI 660848 100 mg oral drinking solution	Drug: BI 660848; 100 mg oral drinking solution
Experimental: BI 660848 150 mg oral drinking solution	Drug: BI 660848; 150 mg oral drinking solution
Experimental: BI 660848 200 mg oral drinking solution	Drug: BI 660848; 200 mg oral drinking solution
Experimental: BI 660848 400 mg oral drinking solution	Drug: BI 660848; 400 mg oral drinking solution
Experimental: BI 660848 600 mg oral drinking solution	Drug: BI 660848; 600 mg oral drinking solution
Experimental: BI 660848 10,0 mg immediate release tablet	Drug: BI 660848; 10,0 mg immediate release tablet
Experimental: BI 660848 50,0 mg immediate release tablet	Drug: BI 660848; 50,0 mg immediate release tablet
Experimental: Placebo matching placebo (oral drinking solution and IR tablets)	Drug: Placebo; matching placebo (oral drinking solution and IR tablets)

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability (number and intensity of adverse events). [4 months]

2. Changes in blood pressure. [4 months]

3. Changes in pulse rate. [4 months]

4. Changes in respiratory rate. [4 months]

5. Changes in 12-lead ECG. [4 months]

6. Changes in clinical laboratory test parameters. [4 months]

Secondary Outcome Measures

1. Cmax (maximum measured concentration of the analyte in plasma) [3 days]

2. tmax (time from dosing to maximum measured concentration) [3 days]

3. AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [3 days]

4. t1/2 (terminal half-life of the analyte in plasma) [3 days]

5. MRT (mean residence time of the analyte in the body after drug intake) [3 days]

6. CL/F (apparent clearance of the analyte in plasma after extravascular administration) [3 days]

7. Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose) [3 days]

8. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [3 days]

9. fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2) [3 days]

10. CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1284.1.1 Boehringer Ingelheim Investigational Site	Ingelheim		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01145014
• Other Study ID Numbers: 1284.1; 2009-015995-90
• First Posted: Jun 16, 2010
• Last Update Posted: Nov 1, 2013
• Last Verified: Oct 1, 2013

Study Results

No Results Posted as of Nov 1, 2013