Status:
COMPLETED
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses and Safety and Pharmacokinetics of BIRT 2584 XX Administered With and Without Food as Single Dose to Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-63 years
Phase:
PHASE1
Brief Summary
The study comprised two parts. The objective of the first study period was to assess the safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without food in male health...
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of the screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age ≥ 18 and ≤ 63 years
- BMI ≥ 18.5 and ≤ 29.9 kg/m2
Exclusion
- Any finding during the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, oncological, or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Relevant history of orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) considered relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (greater than 24 hours) (less than 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial (less than 10 days prior to study drug administration or expected during the trial)
- Participation in another trial with an investigational drug (less than 2 months prior to administration or expected during trial)
- Smoker (more than 10 cigarettes/day or more than 3 cigars/day or more than 3 pipes/day)
- Alcohol abuse (more than 60 g of ethanol per day)
- Drug abuse
- Blood donation or loss greater than 400 mL (less than 1 month prior to administration or expected during the trial)
- Clinically relevant laboratory abnormalities
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02256761
Start Date
January 1 2005
Last Update
October 6 2014
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