Status:
COMPLETED
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects
Eligibility Criteria
Inclusion
- Healthy male subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age \>=18 and \<=50 years
- BMI \>=18.5 and \<=29.9 kg/m2
Exclusion
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, 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) which is deemed relevant to the trial as judged by the investigator
- Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
- Use of any drugs, which might influence the results of the trial, (\< 10 days prior to study drug administration or expected during the trial)
- Participation in another trial with an investigational drug (\< 2 months prior to administration or expected during trial)
- Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
- Alcohol abuse (\> 60 g/day)
- Drug abuse
- Blood donation or loss \> 400 mL, \< 1 month prior to administration or expected during the trial
- Clinically relevant laboratory abnormalities
- Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \> 110 ms or QT interval, Bazett correction (QTcB) \> 450 ms or QT interval \>500 ms
- Inability to comply with dietary regimen of study centre
- Inability to comply with investigator's instructions
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02259894
Start Date
March 1 2004
Last Update
October 9 2014
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