Safety, Tolerability and Pharmacokinetics Study of BI 1744 CL in Healthy Male Subjects

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: BI 1744 CL

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02172131

1222.7

Details and patient eligibility

About

To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL

Enrollment

64 patients

Sex

Male

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (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.
Age ≥21 and ≤45 years
BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
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 the drug or its excipients) as judged clinically relevant by the investigator
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 medication
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 medication
Participation in another trial with an investigational drug within 2 months prior to medication
Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
Inability to refrain from smoking on trial days as judged by the investigator
Alcohol abuse (more than 40 g alcohol a day)
Drug abuse
Blood donation (more than 100 mL blood within 4 weeks prior to medication or during the trial)
Excessive physical activities within 1 week prior to randomisation or during the trial
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of the study centre.