Status:
COMPLETED
Assessment of Exposure of BI 409306 in Cerebrospinal Fluid (CSF) Relative to Plasma as Well as to Evaluation of the Effect of Different Doses of BI 409306 on the cGMP (Cyclic Guanosine Monophosphate) Levels in CSF in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
Due to the exploratory nature of this trial, there is no primary objective in a confirmatory sense. The study aims \- to evaluate the effect of different doses of BI 409306 on biomarker and to assess...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs after 10 minutes in supine position (blood pressure (BP), pulse rate (PR)), body temperature (BT)), 12-lead electrocardiogram (ECG)), clinical laboratory tests
- Age =21 and Age =50 years
- Body Mass Index (BMI) =18.5 and BMI =29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
- Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and considered by the investigator as clinical relevant
- Abnormal values for Prothrombin Time (PT), (Activated Partial Thromboplastin Time (aPTT) and thrombocytes considered by the investigator as clinically relevant
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric 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
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker, who consume more than 5 cigarettes per day
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 20 g/day): 2 units/day (14 units/week)
- 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
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval \>450 ms)
- Inability to understand and to comply with protocol requirements and restrictions and dietary regimen of trial site
- of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until three month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female (intra-uterine device with spermicide, hormonal contraceptive since at least two months)
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01493570
Start Date
December 1 2011
End Date
February 21 2012
Last Update
March 21 2024
Active Locations (1)
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1
1289.3.1 Boehringer Ingelheim Investigational Site
Antwerp, Belgium