Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers
Last updated on April 2022Recruitment
- 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
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (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
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion Criteria
- Signs of intracranial overpressure as determined by funduscopy
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- 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
- ...
- Signs of intracranial overpressure as determined by funduscopy
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- 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
- Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
- Abnormal parameters for thyroid hormones (T3, T4, TSH), coagulation parameters (partial thromboplastin time (aPTT), prothrombin time (PT) and fibrinogen (retests prior inclusion are allowed))
- Blood donation (more than 100 mL within 30 days prior to administration of trial medication or during the trial)
- 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
- History of retinopathy
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Alcohol abuse (consumption of more than 40 g per day)
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or 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 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)
- Drug abuse
- Positive testing on infectious diseases
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position
- Positive testing in the alcohol breath test or the drug screening test
- Chronic or relevant acute infections
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Repeated measurement of pulse rate < 40 bpm and > 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Inability to comply with dietary regimen of trial site
- 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
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
- 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
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
- Inability to refrain from smoking on trial days
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
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
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (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
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion Criteria
- Signs of intracranial overpressure as determined by funduscopy
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- 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
- ...
- Signs of intracranial overpressure as determined by funduscopy
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- 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
- Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
- Abnormal parameters for thyroid hormones (T3, T4, TSH), coagulation parameters (partial thromboplastin time (aPTT), prothrombin time (PT) and fibrinogen (retests prior inclusion are allowed))
- Blood donation (more than 100 mL within 30 days prior to administration of trial medication or during the trial)
- 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
- History of retinopathy
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Alcohol abuse (consumption of more than 40 g per day)
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or 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 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)
- Drug abuse
- Positive testing on infectious diseases
- History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
- Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position
- Positive testing in the alcohol breath test or the drug screening test
- Chronic or relevant acute infections
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Repeated measurement of pulse rate < 40 bpm and > 90 bpm at screening
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Inability to comply with dietary regimen of trial site
- 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
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
- 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
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
- Inability to refrain from smoking on trial days
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
- Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
Tracking Information
- NCT #
- NCT02106247
- Collaborators
- Not Provided
- Investigators
- Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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