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NCT05550636 | Completed | Healthy


A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood
Sponsor:

Boehringer Ingelheim

Brief Summary:

The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.

Condition or disease

Healthy

Intervention/treatment

BI 1015550

midazolam

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 15 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Multiple Oral Doses of BI 1015550 on Metabolism of Midazolam Administered Orally in Healthy Male Subjects (Open-label, Two-period Fixed Sequence Design Trial)
Actual Study Start Date : October 11, 2022
Estimated Primary Completion Date : December 16, 2022
Estimated Study Completion Date : December 16, 2022
Arm Intervention/treatment

Experimental: BI 1015550 + midazolam treatment arm

test and reference treatment arm

Drug: BI 1015550

Drug: midazolam

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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 18 to 55 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion Criteria
  • Any finding in the medical examination (including BP, PR or 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
  • Further exclusion criteria apply

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood

Location Details


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A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Germany,

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany, 68167

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