NCT03325712 is a Phase 1 clinical trial of BI 705564 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT03325712?

NCT03325712 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT03325712?

Interventions in NCT03325712: BI 705564, Placebo, Midazolam.

Is NCT03325712 still recruiting?

NCT03325712 is currently completed. Last updated 7 September 2022.

Are results published for NCT03325712?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-07 · How we verify

NCT03325712

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam

Completed Phase 1 Results posted Last updated 7 September 2022

What this trial tests

Phase 1 trial testing BI 705564 in Healthy in 60 participants. Completed in 26 November 2018.

Timeline

17 November 2017

Primary endpoint
26 November 2018

26 November 2018

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	17 November 2017
Primary completion	26 November 2018
Estimated completion	26 November 2018
Sites	1 location across Germany

Drugs / interventions tested

BI 705564 — full drug profile →
Placebo
Midazolam (midazolam) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 50, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Drug-related Adverse Events Primary · From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564") or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").

Percentage of participants with drug-related adverse events is reported.

Group	Value	95% CI
Placebo Matching BI 705564	20.0
Placebo Matching BI 705564 - SPT	50.0
Dose Group 1: BI 705564 10 mg	12.5
Dose Group 2: BI 705564 20 mg	0.0
Dose Group 3: BI 705564 40 mg	50.0
Dose Group 5: BI 705564 60 mg	50.0
Dose Group 4: BI 705564 80 mg	12.5
Dose Group 8: BI 705564 40 mg - SPT	75.0

Area Under the Concentration-time Curve of BI 705564 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1) Secondary · 1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).

Area under the concentration-time curve of BI 705564 in plasma over a uniform dosing interval τ after administration of the first dose of BI 705564 (AUCτ,1) is reported. Here AUCτ,1 = AUC0-24.

Group	Value	95% CI
Dose Group 1: BI 705564 10 mg	42.1	± 40.6
Dose Group 2: BI 705564 20 mg	70.8	± 31.7
Dose Group 3: BI 705564 40 mg	131.0	± 22.4
Dose Group 5: BI 705564 60 mg	168.0	± 40.1
Dose Group 4: BI 705564 80 mg	238.0	± 46.6
Dose Group 8: BI 705564 40 mg - SPT	120.0	± 33.9

Maximum Measured Concentration of BI 705564 in Plasma (Cmax) After the Administration of the First Dose Secondary · 1 hour(s) (h) prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after first BI 705564 dose (for dose groups 1 to 5); 1.5 h prior drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after first BI 705564 dose (for dose group 8).

Maximum measured concentration of BI 705564 in plasma (Cmax) after the administration of the first dose of BI 705564 is reported.

Group	Value	95% CI
Dose Group 1: BI 705564 10 mg	11.4	± 42.2
Dose Group 2: BI 705564 20 mg	18.8	± 38.2
Dose Group 3: BI 705564 40 mg	36.5	± 17.8
Dose Group 5: BI 705564 60 mg	41.0	± 28.1
Dose Group 4: BI 705564 80 mg	58.1	± 54.4
Dose Group 8: BI 705564 40 mg - SPT	31.7	± 35.2

Area Under the Concentration-time Curve of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Administration of the Last Dose Secondary · 1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).

Area under the concentration-time curve of BI 705564 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the administration of the last dose of BI 705564 is reported. As per the protocol, day is counted as "Day 1 = 0:00".

Group	Value	95% CI
Dose Group 1: BI 705564 10 mg	45.9	± 34.2
Dose Group 2: BI 705564 20 mg	84.8	± 25.9
Dose Group 3: BI 705564 40 mg	164.0	± 34.3
Dose Group 5: BI 705564 60 mg	170.0	± 62.1
Dose Group 4: BI 705564 80 mg	204.0	± 179.0
Dose Group 8: BI 705564 40 mg - SPT	138.0	± 32.1

Maximum Measured Concentration of BI 705564 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Administration of the Last Dose Secondary · 1 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h after last BI 705564 dose on Day 17 (for dose groups 1 to 5); 1.5 h before last dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 23 h after last BI 705564 dose on Day 28 (for dose group 8).

Maximum measured concentration of BI 705564 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the administration of the last dose. As per the protocol, day is counted as "Day 1 = 0:00".

Group	Value	95% CI
Dose Group 1: BI 705564 10 mg	13.3	± 29.4
Dose Group 2: BI 705564 20 mg	19.8	± 23.7
Dose Group 3: BI 705564 40 mg	41.8	± 21.4
Dose Group 5: BI 705564 60 mg	43.4	± 57.2
Dose Group 4: BI 705564 80 mg	52.6	± 201.0
Dose Group 8: BI 705564 40 mg - SPT	39.2	± 28.3

Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) After the First and Last Dose Secondary · 1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.

Area under the concentration-time curve of Midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.

After last dose: Midazolam + BI705564 or Midazolam + Placebo (Treatment (T))

Group	Value	95% CI
Placebo Matching BI 705564	4478.58	± NA
Dose Group 2: BI 705564 20 mg	3463.24	± NA
Dose Group 3: BI 705564 40 mg	4812.45	± NA
Dose Group 5: BI 705564 60 mg	3458.32	± NA
Dose Group 4: BI 705564 80 mg	3759.20	± NA

After first dose: Midazolam alone (Reference (R))

Group	Value	95% CI
Placebo Matching BI 705564	4356.03	± NA
Dose Group 2: BI 705564 20 mg	3721.70	± NA
Dose Group 3: BI 705564 40 mg	4382.24	± NA
Dose Group 5: BI 705564 60 mg	3191.16	± NA
Dose Group 4: BI 705564 80 mg	3445.42	± NA

Maximum Measured Concentration of Midazolam in Plasma (Cmax) After the First and Last Dose Secondary · 1.5 h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after first midazolam dose on Day -1 and 1h prior midazolam administration and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 h after last midazolam dose on Day 17.

Maximum measured concentration of Midazolam in plasma (Cmax) after the first and last dose for "Placebo Matching BI 705564" group and for dose groups 2 to 5 is reported.

After last dose: Midazolam +BI 705564 or Midazolam +Placebo (Treatment (T))

Group	Value	95% CI
Placebo Matching BI 705564	1197.89	± NA
Dose Group 2: BI 705564 20 mg	1040.42	± NA
Dose Group 3: BI 705564 40 mg	1255.36	± NA
Dose Group 5: BI 705564 60 mg	984.14	± NA
Dose Group 4: BI 705564 80 mg	1058.32	± NA

After first dose: Midazolam alone (Reference (R))

Group	Value	95% CI
Placebo Matching BI 705564	1196.63	± NA
Dose Group 2: BI 705564 20 mg	1232.26	± NA
Dose Group 3: BI 705564 40 mg	1147.40	± NA
Dose Group 5: BI 705564 60 mg	1031.18	± NA
Dose Group 4: BI 705564 80 mg	1175.41	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug administration until 10 days after last drug administration, up to 27 days (for dose groups 1 to 5 and "Placebo Matching BI 705564" ) or up to 37 days (for dose group 8 and "Placebo Matching BI 705564 - SPT").. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Matching BI 705564

Serious: 0/10 (0%)

Deaths: 0/10

Placebo Matching BI 705564 - SPT

Serious: 0/2 (0%)

Deaths: 0/2

Dose Group 1: BI 705564 10 mg

Serious: 0/8 (0%)

Deaths: 0/8

Dose Group 2: BI 705564 20 mg

Serious: 0/8 (0%)

Deaths: 0/8

Dose Group 3: BI 705564 40 mg

Serious: 0/8 (0%)

Deaths: 0/8

Dose Group 5: BI 705564 60 mg

Serious: 0/8 (0%)

Deaths: 0/8

Dose Group 4: BI 705564 80 mg

Serious: 0/8 (0%)

Deaths: 0/8

Dose Group 8: BI 705564 40 mg - SPT

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (38 terms — click to expand)

Reaction	System	Placebo Matching BI 705564	Placebo Matching BI 705564…	Dose Group 1: BI 705564 10…	Dose Group 2: BI 705564 20…	Dose Group 3: BI 705564 40…	Dose Group 5: BI 705564 60…	Dose Group 4: BI 705564 80…	Dose Group 8: BI 705564 40…
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—
Vessel puncture site haematoma	General disorders	—	—	—	—	—	—	—	—
Herpes simplex	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Limb discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Spinal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—	—	—
Orthostatic intolerance	Nervous system disorders	—	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03325712 adverse events section.

Sponsor's own description

The primary objective of this trial is to investigate safety and tolerability of BI 705564 in healthy male subjects, following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics, including dose proportionality and investigation of linearity.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety, pharmacokinetics and pharmacodynamics of BI 705564, a highly selective, covalent inhibitor of Bruton's tyrosine kinase, in Phase I clinical trials in healthy volunteers.
Litzenburger T, Steffgen J, Benediktus E, Müller F, et al · · 2021 · cited 5× · PMID 32986868 · DOI 10.1111/bcp.14571

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03325712 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 7 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03325712.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03325712

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of BI 705564

Other recruiting trials for Healthy

Other Boehringer Ingelheim trials

Verify against primary sources