Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Administered to Healthy Male Subjects

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: BI 44847

Study type

Interventional

Funder types

Industry

Identifiers

NCT02211924

1224.11

Details and patient eligibility

About

Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 44847 in Japanese healthy volunteers

Enrollment

48 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects will be healthy male volunteers who meet the criteria below:
- Persons without clinically remarkable findings or clinically evident complications based on their concurrent illness, past medical history, physical examination, vital signs (blood pressure, pulse rate, and body temperature), 12-lead ECG, and laboratory test results
- Persons who are 20 or older and 35 or younger
- Persons with a BMI 18.5 kg/m2 or more and 25.0 kg/m2 less
- Persons who are willing to participate in this trial before study initiation and who give their written consent in accordance with Good Clinical Practice

Exclusion criteria

Any finding of the medical examination (including BP, Pulse Rate (PR) and ECG) deviating from normal and of clinical relevance
Any 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 drug or its excipients)
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
Use of any drugs within 10 days prior to administration or during the trial
Participation in another trial with an investigational drug within four months prior to administration or during the trial
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 60 g/day)
Drug abuse
Blood donation (more than 100 mL) within four weeks prior to administration or during the trial
Excessive physical activities (within one week prior to administration or during the trial)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of study centre 19. A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
The use of concomitant medications that prolong the QT/QTc interval
Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval >120 ms
Elevated urinary glucose levels at screening (>15 mg/dl)