A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BI 1569912

Study type: Interventional

Funder types: Industry

Identifiers

NCT04978506

1447-0002

2021-001717-36 (EudraCT Number)

Details and patient eligibility

About

The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.

Enrollment: 83 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

• MRD- and POSO-part: Age of 18 to 45 years (inclusive); ELDERLY-part: Age of 65 to 80 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 GCP and local legislation

• Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  • Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
  • Sexually abstinent
  • Surgically sterilised (including hysterectomy of female partner)
  • Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
• 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/ convulsions or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or unexplained blackouts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 9 patient groups, including a placebo group

Placebo group for MRD part

Placebo Comparator group

Description:

Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.

Treatment:

Drug: Placebo

Placebo for elderly treatment group

Placebo Comparator group

Description:

Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.

Treatment:

Drug: Placebo

BI 1569912 2.5 mg treatment group (MRD)

Experimental group

Description:

Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.

Treatment:

Drug: BI 1569912

BI 1569912 5 mg treatment group (MRD)

Experimental group

Description:

Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.

Treatment:

Drug: BI 1569912

BI 1569912 10 mg treatment group (MRD)

Experimental group

Description:

Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.

Treatment:

Drug: BI 1569912

BI 1569912 20 mg treatment group (MRD)

Experimental group

Description:

Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.

Treatment:

Drug: BI 1569912

BI 1569912 30 mg treatment group (MRD)

Experimental group

Description:

Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.

Treatment:

Drug: BI 1569912

BI 1569912 40 mg treatment group (MRD)

Experimental group

Description:

Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.

Treatment:

Drug: BI 1569912

BI 1569912 elderly 10/20 mg treatment group

Experimental group

Description:

Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.

Treatment:

Drug: BI 1569912