A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo matching BI 3731579; Drug: BI 3731579; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06716190

1519-0002

U1111-1313-5393 (Registry Identifier)

2024-517209-95-00 (Registry Identifier)

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Healthy volunteers 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), respiratory rate (RR) and temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria

1. Any finding in the medical examination (including BP, PR, RR, temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or resting pulse rate outside the range of 45 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 5 patient groups, including a placebo group

MRD: BI 3731579 dose group 1

Experimental group

Description:

MRD= Multiple rising doses

Treatment:

Drug: Midazolam

Drug: BI 3731579

MRD: BI 3731579 dose group 2

Experimental group

Treatment:

Drug: Midazolam

Drug: BI 3731579

MRD: BI 3731579 dose group 3

Experimental group

Treatment:

Drug: Midazolam

Drug: BI 3731579

MRD: BI 3731579 dose group 4

Experimental group

Treatment:

Drug: Midazolam

Drug: BI 3731579

MRD: Placebo matching BI 3731579

Placebo Comparator group

Treatment:

Drug: Midazolam

Drug: Placebo matching BI 3731579