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

NCT04978506 | Completed Phase 1 Results

• 2 other identifiers: 1447-00022021-001717-36
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Drug-related Adverse Events

  Number of subjects with drug-related adverse events is reported.

  Up to Day 27

Secondary Outcomes (7)

• Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)

  Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.

• Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax)

  Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.

• Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose

  Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.

• Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose

  Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.

• Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose

  Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.

Study Arms (9)

Placebo group for MRD part

PLACEBO COMPARATOR

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.

Drug: Placebo

Placebo for elderly treatment group

PLACEBO COMPARATOR

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.

Drug: Placebo

BI 1569912 2.5 mg treatment group (MRD)

EXPERIMENTAL

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.

Drug: BI 1569912

BI 1569912 5 mg treatment group (MRD)

EXPERIMENTAL

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.

Drug: BI 1569912

BI 1569912 10 mg treatment group (MRD)

EXPERIMENTAL

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.

Drug: BI 1569912

BI 1569912 20 mg treatment group (MRD)

EXPERIMENTAL

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.

Drug: BI 1569912

BI 1569912 30 mg treatment group (MRD)

EXPERIMENTAL

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.

Drug: BI 1569912

BI 1569912 40 mg treatment group (MRD)

EXPERIMENTAL

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.

Drug: BI 1569912

BI 1569912 elderly 10/20 mg treatment group

EXPERIMENTAL

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.

Drug: BI 1569912

Interventions

BI 1569912 DRUG

BI 1569912

BI 1569912 10 mg treatment group (MRD); BI 1569912 2.5 mg treatment group (MRD); BI 1569912 20 mg treatment group (MRD); BI 1569912 30 mg treatment group (MRD); BI 1569912 40 mg treatment group (MRD); BI 1569912 5 mg treatment group (MRD); BI 1569912 elderly 10/20 mg treatment group

Placebo DRUG

Placebo

Placebo for elderly treatment group; Placebo group for MRD part

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 27, 2021
• Study Start: September 3, 2021
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: June 26, 2026
• Results First Posted: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)