Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773 single rising dose; Drug: Placebo

• Registration Number: NCT02172170
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single rising oral doses of BI 10773 to healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-03
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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 ≥ 18 and Age ≤ 50 years

3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Read More

Exclusion Criteria

1. Any finding of the medical examination including ((blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (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 (such as epilepsy) or psychiatric disorders or neurological disorders

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. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial

10. 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

11. Participation in another trial with an investigational drug within two months prior to administration or during the trial

12. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

13. Inability to refrain from smoking on trial days

14. Alcohol abuse (more than 60 g/day)

15. Drug abuse

16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

17. Excessive physical activities (within one week prior to administration or during the trial)

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

19. Inability to comply with the dietary regimen of trial site

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

21. A history of additional risk factors for torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome);

    Exclusion criteria specific for this study:

22. Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 10773 single rising dose	BI 10773 single rising dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 33 days
Number of patients with clinically significant changes in vital signs	up to 12 days
Assessment of tolerability by investigator on a 4-point scale	up to day 4
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)	up to 12 days
Number of patients with abnormal findings in physical examination	up to 12 days
Number of patients with abnormal changes in laboratory parameters	up to 12 days

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum concentration of the analyte in plasma)	up to 72 hours after drug administration
tmax (time from dosing to maximum concentration)	up to 72 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72 hours after drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)	up to 72 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)	up to 72 hours after drug administration
λz (terminal rate constant in plasma)	up to 72 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)	up to 72 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)	up to 72 hours after drug administration
CL/F (total clearance of the analyte in the plasma after extravascular administration)	up to 72 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)	up to 72 hours after drug administration
Ae t1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)	up to 72 hours after drug administration
fe t1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)	up to 72 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)	up to 72 hours after drug administration