Status:
COMPLETED
Single Increasing Dose Tolerance Study in Healthy Male Volunteers of BIIR 561 CL
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
The objective of the study is to obtain information about safety, tolerability and pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses in healthy male volunteer...
Eligibility Criteria
Inclusion
- Healthy male volunteers
- Age 21 to 50 years
- Broca index from -20% to +20%
- Written informed consent prior to admission to the study
Exclusion
- Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values
- Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders
- Known history of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Intake of a drug with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
- Intake of any other drug which might influence the results of the trial during the week previous to the start of the study
- Participation in another study with an investigational drug within the last two - months preceding this study
- Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
- Alcohol use of more than 60 g per day
- Drug dependency
- Excessive physical activities (e.g. competitive sports) within the last week before the study
- Blood donation within the last 4 weeks (\>= 100 ml)
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02222974
Start Date
January 1 1999
Last Update
August 22 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.