A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: rosuvastatin; Drug: Placebo matching BI 1839100; Drug: digoxin; Drug: midazolam; Drug: BI 1839100

Study type: Interventional

Funder types: Industry

Identifiers

NCT05738291

1490-0002

2022-003161-38 (EudraCT Number)

Details and patient eligibility

About

Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.

Enrollment: 67 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Physically and mentally 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 31.9 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm) (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
• 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 assessed as clinically relevant by the investigator
• 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 assessed as clinically relevant by the investigator
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 7 patient groups, including a placebo group

MRD part: BI 1839100 dose group 1

Experimental group

Description:

Multiple rising dose (MRD)

Treatment:

Drug: BI 1839100

MRD part: BI 1839100 dose group 2

Experimental group

Description:

Multiple rising dose (MRD)

Treatment:

Drug: BI 1839100

MRD part: BI 1839100 dose group 3

Experimental group

Description:

Multiple rising dose (MRD)

Treatment:

Drug: BI 1839100

MRD part: BI 1839100 dose group 4

Experimental group

Description:

Multiple rising dose (MRD)

Treatment:

Drug: BI 1839100

MRD part: BI 1839100 dose group 5

Experimental group

Description:

Multiple rising dose (MRD)

Treatment:

Drug: BI 1839100

MRD part: Placebo matching BI 1839100

Placebo Comparator group

Treatment:

Drug: Placebo matching BI 1839100

DDI part

Experimental group

Description:

Drug-Drug Interaction (DDI)

Treatment:

Drug: BI 1839100

Drug: midazolam

Drug: digoxin

Drug: rosuvastatin