Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: BI 1467335 Drug: Placebo Drug: Phenelzine sulfate Drug: Tyramine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Parallel Group Study in Healthy Subjects to Evaluate the Effect of Multiple Oral Doses of BI 1467335 and Phenelzine as Positive Control on Blood Pressure Response to Oral Tyramine (Double-blind, Randomised, Placebo-controlled Design for BI 1467335 Treatment Groups, Open Label for Phenelzine) |
Actual Study Start Date : | July 31, 2019 |
Actual Primary Completion Date : | April 8, 2020 |
Actual Study Completion Date : | April 8, 2020 |
Arm | Intervention/treatment |
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Experimental: 10 mg BI 1467335/10 mg BI 1467335 + Tyramine |
Drug: BI 1467335
Film-coated tablet
Drug: Tyramine Capsules
|
Experimental: 15 mg BI 1467335/15 mg BI 1467335 + Tyramine |
Drug: BI 1467335
Film-coated tablet
Drug: Tyramine Capsules
|
Active Comparator: Phenelzine/Phenelzine + Tyramine |
Drug: Phenelzine sulfate
Film-coated tablet
Drug: Tyramine Capsules
|
Placebo Comparator: Placebo/Placebo + Tyramine |
Drug: Placebo
Film-coated tablet
Drug: Tyramine Capsules
|
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male subjects, or female subjects who meet any of the following criteria before the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
Female subjects will not be allowed to participate, if any of the following apply:
Netherlands | |
PRA Health Sciences Onderzoekscentrum Martini | |
Groningen, Netherlands, 9728 NZ |
Tracking Information | |||||
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First Submitted Date ICMJE | June 6, 2019 | ||||
First Posted Date ICMJE | June 7, 2019 | ||||
Results First Submitted Date ICMJE | May 11, 2021 | ||||
Results First Posted Date ICMJE | June 4, 2021 | ||||
Last Update Posted Date | June 4, 2021 | ||||
Actual Study Start Date ICMJE | July 31, 2019 | ||||
Actual Primary Completion Date | April 8, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Tyramine Sensitivity Factor (TSF) [ Time Frame: At baseline (Day -11 up to Day-2) and at steady state (Day 29 up to Day 39 for the "Placebo/Placebo + Tyramine" and "10 mg BI 1467335/10 mg BI 1467335 + Tyramine" arms, Day 8 up to Day 19 for the "Phenelzine/ Phenelzine + Tyramine" arm). ] TSF was defined as ratio of the tyramine dose causing an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30) at baseline and at steady state of BI 1467335, placebo or phenelzine. Geometric Mean is the Geometric Least Squares Mean and is extracted from the ANOVA model that includes all treatments. Standard error is the geometric standard error of the mean (gSE) and is extracted from the ANOVA model that includes all treatments.
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Original Primary Outcome Measures ICMJE |
Tyramine Sensitivity Factor (TSF) [ Time Frame: Up to 39 days ] Tyramine sensitivity factor (TSF), defined as ratio of the tyramine dose causing an increase of systolic blood pressure (SBP) ≥ 30 mmHg for at least 3 consecutive measurements (TYR30) at baseline and at steady state following multiple oral doses of BI 1467335, placebo or phenelzine
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure | ||||
Official Title ICMJE | A Phase I Parallel Group Study in Healthy Subjects to Evaluate the Effect of Multiple Oral Doses of BI 1467335 and Phenelzine as Positive Control on Blood Pressure Response to Oral Tyramine (Double-blind, Randomised, Placebo-controlled Design for BI 1467335 Treatment Groups, Open Label for Phenelzine) | ||||
Brief Summary | The main objective of the study is investigate the effect of escalating doses of oral tyramine on systolic blood pressure (SBP) at baseline and following an oral treatment with BI 1467335 up to 39 days at a low or high dose once daily compared to placebo and phenelzine (Nardil®) as positive control. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
53 | ||||
Original Estimated Enrollment ICMJE |
62 | ||||
Actual Study Completion Date ICMJE | April 8, 2020 | ||||
Actual Primary Completion Date | April 8, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Female subjects will not be allowed to participate, if any of the following apply:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Netherlands | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03979820 | ||||
Other Study ID Numbers ICMJE | 1386.16 2018-003965-32 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Boehringer Ingelheim | ||||
Study Sponsor ICMJE | Boehringer Ingelheim | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Boehringer Ingelheim | ||||
Verification Date | March 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |