Safety Tolerability and Pharmacokinetic of BI 409306

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01343706
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 14

Study Details

Study Description

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses.

The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo; Drug: Placebo .; Drug: BI 409306	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses 0.5 mg to 500 mg of BI 409306 Administered Orally in Healthy Male Volunteers
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 409306 dose 1 Solution for oral administration	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 2 Solution for oral administration	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 3 Solution for oral administration	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 4 Solution for oral administration	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 5 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 6 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 7 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 8 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 9 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 10 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 11 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Experimental: BI 409306 dose 12 Immediate release solid oral dosage	Drug: BI 409306; Immediate release solid oral dosage medium
Placebo Comparator: Placebo Solution for oral administration	Drug: Placebo; Solution for oral administration
Placebo Comparator: Placebo 2 Immediate release solid oral dosage	Drug: Placebo .; Immediate release solid oral dosage

Outcome Measures

Primary Outcome Measures

1. Physical examination (respiratory, gastro-intestinal, musculoskeletal) [18 weeks]

2. Vital signs [18 weeks]

3. 12-lead ECG (electrocardiogram) [18 weeks]

4. Clinical laboratory tests (haematology: haemoglobin; haematocrit/erythrocytes; haemoglobin/erythroctes; Erythro-, leuco-,lympho-, mono-Cytes; Platelets) [18 weeks]

5. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [18 weeks]

6. Assessment of tolerability by investigator [18 weeks]

7. Clinical laboratory tests (clinical chemistry: electrolytes;liver enzymes, bilirubin, amylase, lipase, cholesterol) [18 weeks]

8. Clinical laboratory tests (urinanalysis: pH, nitrite, protein, glucose, ketones, red blood cells, white blood cells, bacteria, crystals) [18 weeks]

9. Changes from baseline in Bond-Lader Visual Analogue Scales [Up to 24 h after drug administration]

Secondary Outcome Measures

1. Cmax (maximum measured concentration of the analyte in plasma) [18 weeks]

2. AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [18 weeks]

3. AUC0-tz (area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point) [18 weeks]

4. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [18 weeks]

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 males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

2. Age > 21 and Age < 50 years

3. Body Mass Index (BMI) > 18.5 and BMI < 29.9 kg/m2

Exclusion criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance

2. Any evidence of a clinically relevant concomitant disease

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

4. Surgery of the gastrointestinal tract (except appendectomy)

5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) within the past 6 month

6. History of relevant orthostatic hypotension, fainting spells or blackouts.

7. Chronic or relevant acute infections

8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

9. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial

10. Any laboratory value outside the reference range that is of clinical relevance

11. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);

12. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1289.1.1 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

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01343706
• Other Study ID Numbers: 1289.1; 2010-023604-27
• First Posted: Apr 28, 2011
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: BI 409306

Study Results

No Results Posted as of Aug 31, 2018