A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood

NCT04445090 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 1447-00012019-004836-51
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)

  Number of participants with drug-related adverse events (AEs) is presented for SRD part. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.

  From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.

• BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

  Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

• BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)

  Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.

  Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Secondary Outcomes (3)

• SRD Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)

  Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.

• SRD-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)

  Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.

• BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)

  Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Study Arms (14)

SRD part: Placebo

PLACEBO COMPARATOR

This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: Placebo

SRD part: 0.25mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

SRD part: 0.75mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

SRD part: 2.0 mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

SRD part: 5.0 mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

SRD part: 10.0 mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

SRD part: 20.0 mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

SRD part: 30.0 mg BI 1569912

EXPERIMENTAL

Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.

Drug: BI 1569912

BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed

EXPERIMENTAL

Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Drug: BI 1569912

BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted

EXPERIMENTAL

Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Drug: BI 1569912

BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed

EXPERIMENTAL

Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Drug: BI 1569912

BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted

EXPERIMENTAL

Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Drug: BI 1569912

BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted

EXPERIMENTAL

Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Drug: BI 1569912

BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted

EXPERIMENTAL

Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Drug: BI 1569912

Interventions

BI 1569912 DRUG

BI 1569912

BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed; BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted; BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed; BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted; BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted; BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted; SRD part: 0.25mg BI 1569912; SRD part: 0.75mg BI 1569912; SRD part: 10.0 mg BI 1569912; SRD part: 2.0 mg BI 1569912; SRD part: 20.0 mg BI 1569912; SRD part: 30.0 mg BI 1569912; SRD part: 5.0 mg BI 1569912

Placebo DRUG

Placebo

SRD part: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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), respiratory rate (RR), temperature (T)), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 45 years (inclusive)
• 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 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, 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)
• History of relevant orthostatic hypotension, fainting spells, or any unexplained blackouts
• Chronic or relevant acute infections
• A positive polymerase chain reaction (PCR) test for SARS-CoV-2/COVID-19 and/ or any clinical symptom suggestive for this disease at screening and on Day -3.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Links

• Related Info

Limitations and Caveats

The trial was set on temporary hold on 06 Sep 2021 and was terminated on 07 Oct 2021 due to the identification of a metabolite of BI 1569912 which was classified as Class 2 substance (according to ICH M7 \[R1\] guideline) as a result of a positive Ames test. Further analysis is ongoing to find out if BI 1569912 can safely be dosed in subsequent trials.

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

Model Details: SRD-Part: parallel-group design BA/FE-Part: three-way crossover design

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 21, 2020
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)