Recruitment

Recruitment Status
Completed

Inclusion Criteria

Healthy males according to the investigator´s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
BMI 18.5 to 29.9 kg/m2 (incl.)
Age 18 to 50 years (incl.)
...
Healthy males according to the investigator´s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
BMI 18.5 to 29.9 kg/m2 (incl.)
Age 18 to 50 years (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria

Positive testing on infectious diseases
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
...
Positive testing on infectious diseases
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
Positive testing in the alcohol breath test or the drug screening test
Inability to comply with dietary regimen of trial site
Abnormal parameters for thyroid hormones (T3, T4, TSH), coagulation parameters (partial thromboplastin time (aPTT), prothrombin time (PT) and fibrinogen (retests prior inclusion are allowed))
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Any evidence of a concomitant disease judged clinically relevant by the investigator
Chronic or relevant acute infections
Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the trial completion. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least two month prior trial participation)
Inability to refrain from smoking on trial days
Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
Alcohol abuse (consumption of more than 40 g per day)
Signs of intracranial overpressure as determined by funduscopy
History of retinopathy
Repeated measurement of pulse rate < 40 bpm and > 90 bpm at screening
History of relevant orthostatic hypotension, fainting spells, or blackouts
Drug abuse
Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
Any history or present disease of the central nervous system, the spinal cord or the spinal column, which could provoke complications with procedure of the lumbar catheterization/intrathecal punction
Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
Blood donation (more than 100 mL within 30 days prior to administration of trial medication or during the trial)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
At screening, a marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTcF interval >450 ms) or any other relevant ECG finding
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Double
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

Inclusion Criteria

Healthy males according to the investigator´s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
BMI 18.5 to 29.9 kg/m2 (incl.)
Age 18 to 50 years (incl.)
...
Healthy males according to the investigator´s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
BMI 18.5 to 29.9 kg/m2 (incl.)
Age 18 to 50 years (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria

Positive testing on infectious diseases
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
...
Positive testing on infectious diseases
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
Positive testing in the alcohol breath test or the drug screening test
Inability to comply with dietary regimen of trial site
Abnormal parameters for thyroid hormones (T3, T4, TSH), coagulation parameters (partial thromboplastin time (aPTT), prothrombin time (PT) and fibrinogen (retests prior inclusion are allowed))
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Any evidence of a concomitant disease judged clinically relevant by the investigator
Chronic or relevant acute infections
Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the trial completion. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least two month prior trial participation)
Inability to refrain from smoking on trial days
Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
Alcohol abuse (consumption of more than 40 g per day)
Signs of intracranial overpressure as determined by funduscopy
History of retinopathy
Repeated measurement of pulse rate < 40 bpm and > 90 bpm at screening
History of relevant orthostatic hypotension, fainting spells, or blackouts
Drug abuse
Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
Any history or present disease of the central nervous system, the spinal cord or the spinal column, which could provoke complications with procedure of the lumbar catheterization/intrathecal punction
Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
Blood donation (more than 100 mL within 30 days prior to administration of trial medication or during the trial)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
At screening, a marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTcF interval >450 ms) or any other relevant ECG finding
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position

Locations

Antwerpen
Antwerpen

Tracking Information

NCT #
NCT02106247
Collaborators
Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim