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A Study in Healthy Men to Test the Effects of Different Doses of BI 1467335 on MAO-B Activity in the Brain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927209
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective of this trial is to investigate the effect of multiple oral dosing of high dose BI 1467335 over 28 days and multiple oral dosing of low dose BI 1467335 over 42 days on MAO-B occupancy in the brain compared to baseline using [11C]-L-deprenyl-D2 PET tracer in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1467335 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Positron Emission Tomography Study in Healthy Male Subjects to Explore the Inhibition of Monoamine Oxidase B in the Brain After Multiple Oral Doses of BI 1467335 (Non-randomized, Open-label, Parallel-group Study)
Actual Study Start Date : June 6, 2019
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019

Arm Intervention/treatment
Experimental: BI 1467335 (low dose) Drug: BI 1467335
tablet

Experimental: BI 1467335 (high dose) Drug: BI 1467335
tablet




Primary Outcome Measures :
  1. % reduction in Monoamine oxidase B (MAO-B) availability upon treatment with BI 1467335 on the last treatment day (Day 28 for the high dose group and Day 42 for the low dose group) compared to baseline [ Time Frame: Baseline, Day 28, Day 42 ]

Secondary Outcome Measures :
  1. % reduction in Monoamine oxidase B (MAO-B) availability upon treatment with high dose BI 1467335 on Day 14 compared to baseline [ Time Frame: Baseline, Day 14 ]
  2. % reduction in Monoamine oxidase B (MAO-B) availability upon treatment with low dose BI 1467335 on Day 28 compared to baseline [ Time Frame: Baseline, Day 28 ]
  3. Percentage of Monoamine oxidase B (MAO-B) inhibition in platelet rich plasma at Day 14 (high dose group only), Day 28, and Day 42 (low dose group only) compared to baseline [ Time Frame: Baseline, Day14, Day 28, Day 42 ]
  4. Cmax,N (maximum measured concentration of the analyte) on Day 14 (high dose group only), Day 28 and Day 42 (low dose group only) [ Time Frame: Up to 24 hours ]
  5. AUC0-24, N (area under the concentration-time curve of the analyte over the time interval from 0 to 24 h) on Day 14 (high dose group only), Day 28 and Day 42 (low dose group only) [ Time Frame: Up to 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • Age of 21 to 55 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
  • Non-smoker with no history of smoking
  • Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:

    • Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
    • Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
    • Condoms plus surgically sterilised partner (including hysterectomy) or
    • Condoms plus intrauterine device or
    • Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner to the study drug via seminal fluid. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, with their partner, they must comply with the contraceptive requirements detailed above.

Exclusion criteria:

  • Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, fainting spells, or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
  • Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
  • Intake of an investigational drug in another clinical trial within 90 days or within 5 half-lives, whichever is longer, of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
  • Alcohol abuse (consumption of more than 30 g per day for males) within the 24 months prior to dosing
  • Drug abuse within the 24 months prior to dosing or positive drug screening
  • Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
  • Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
  • Inability to comply with the dietary regimen of the trial site
  • A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
  • A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
  • Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
  • Structural brain abnormality has been shown on an Magnetic Resonance Imaging (MRI)
  • Severe anxiety of enclosed spaces
  • Contraindication for arterial cannulation: Allen's test indicating potential risk in placement of the arterial cannula.
  • Contraindication to MRI as determined by screening and safety questionnaire including but not limited to significant tattoos (as determined by the radiographer), cardiac pacemakers, aneurysm clips and cochlear implants.
  • Unable to lie flat on the MRI or Positron emission tomography (PET) scanner for a prolonged period of time.
  • Prior participation in other research protocols in the past year such that the total effective dose including this study would exceed 10 mSv.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927209


Locations
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United Kingdom
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03927209    
Other Study ID Numbers: 1386-0022
2018-003745-41 ( EudraCT Number )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No