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).

Healthy Clinical Trial

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01145014
• Other study ID #: 1284.1
• Secondary ID: 2009-015995-90
• Status: Terminated
• Phase: Phase 1
• First received: May 5, 2010
• Last updated: October 31, 2013
• Start date: May 2010

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Pain

Intervention

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

Locations

Country	Name	City	State
Germany	1284.1.1 Boehringer Ingelheim Investigational Site	Ingelheim

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (number and intensity of adverse events).		4 months	No
Primary	Changes in blood pressure.		4 months	No
Primary	Changes in pulse rate.		4 months	No
Primary	Changes in respiratory rate.		4 months	No
Primary	Changes in 12-lead ECG.		4 months	No
Primary	Changes in clinical laboratory test parameters.		4 months	No
Secondary	Cmax (maximum measured concentration of the analyte in plasma)		3 days	No
Secondary	tmax (time from dosing to maximum measured concentration)		3 days	No
Secondary	AUC (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)		3 days	No
Secondary	t1/2 (terminal half-life of the analyte in plasma)		3 days	No
Secondary	MRT (mean residence time of the analyte in the body after drug intake)		3 days	No
Secondary	CL/F (apparent clearance of the analyte in plasma after extravascular administration)		3 days	No
Secondary	Vz/F (apparent volume of distribution during the terminal phase following an extravascular dose)		3 days	No
Secondary	Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)		3 days	No
Secondary	fet1-t2 (fraction of analyte eliminated in urine from the time point t1 to time point t2)		3 days	No
Secondary	CL R,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)		3 days	No