HealthyPhase 1NCT03123185

Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects

A Phase 1 study testing BI 705564 (Test) and BI 705564 (Reference) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 705564 (Test) and BI 705564 (Reference)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 1 siteGermany
Study dates: 27 Apr 2017to 19 Feb 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, 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 50 years (incl.)
Body Mass Index [BMI] of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice [GCP] and local legislation

Who cannot join

-- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140mmHg, 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
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/ or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 28Show fewer

Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days prior to administration of trial medication, if that might reasonably influence the results of the trial (incl. QT/ QTc interval prolongation)
Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 30 g per day)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of the trial site
A marked baseline prolongation of QT/ QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant Electrocardiogram [ECG] finding at screening
A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
In addition, the following trial-specific exclusion criteria apply:
Male subjects with women of childbearing potential [WOCBP] partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication
Repeated absolute B cell (CD19+) counts below 40/μL at screening
Repeated platelet counts below 100 cells/nL at screening
Serum potassium below normal range at screening
A history or current clinical signs of acute pancreatitis

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 705564 (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Food Effect on a Tablet Formulation of BI 705564 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects

Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects

Read the detailed description

The primary objective of the single rising dose part under fasting and under fed conditions is to investigate safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality, and pharmacodynamics (PD) of BI 705564 after single rising doses.

The objective of the food effect part is to explore the relative bioavailability of BI 705564 tablets under fed and fasted conditions following the oral administration of single doses.

Conditions: Healthy
Being tested: Placebo, BI 705564 (Test), BI 705564 (Reference)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Tablet and solution formulation
BI 705564 (Test)Drug
Fed state
BI 705564 (Reference)Drug
Fasting state

Study groups in NCT03123185
Study group	Role	What they receive
Placebo matching BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: Placebo
Placebo matching BI 705564 fed (SRD part)	Experimental	Not described Receives: Drug: Placebo
1 milligram (mg) BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Reference)
3 mg BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Reference)
10 mg BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Reference)
20 mg BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Reference)
40 mg BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Reference)
80 mg BI 705564 fasted (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Reference)
20 mg BI 705564 fed (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Test)
40 mg BI 705564 fed (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Test)
80 mg BI 705564 fed (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Test)
160 mg BI 705564 fed (SRD part)	Experimental	Not described Receives: Drug: BI 705564 (Test)
BI 705564 10 mg fasted/ BI 705564 10 mg fed (FE Part)	Experimental	Not described Receives: Drug: BI 705564 (Test); Drug: BI 705564 (Reference)
BI 705564 10 mg fed/ BI 705564 10 mg fasted (FE Part)	Experimental	Not described Receives: Drug: BI 705564 (Test); Drug: BI 705564 (Reference)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants 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.
Measured: From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part)
AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented.
Measured: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part)
Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part.
Measured: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.

Secondary outcomes (3)

Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part)
Cmax, maximum measured concentration of BI 705564 in plasma is presented for SRD part.
Measured: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part)
AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity is presented for SRD part.
Measured: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part)
AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity.
Measured: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 201719 Feb 2018

First posted21 Apr 2017
Study start27 Apr 2017
Primary completion19 Feb 2018
Study completion19 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03123185
Sponsor's protocol ID: 1408-0001
Other IDs: 2017-000324-98, 2017
Status last verified: Mar 2022
First submitted: 13 Apr 2017
Last updated: 6 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 705564 (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Food Effect on a Tablet Formulation of BI 705564 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03123185
Acronym / sponsor ID: 1408-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 27 Apr 2017 (actual)
Primary completion: 19 Feb 2018 (actual)
Study completion: 19 Feb 2018 (actual)
First posted: 21 Apr 2017 (actual)
Results: Posted 6 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects

Detailed description

Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality, and pharmacodynamics (PD) of BI 705564 after single rising doses.

The objective of the food effect part is to explore the relative bioavailability of BI 705564 tablets under fed and fasted conditions following the oral administration of single doses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 14

Arm	Type	Receives
Placebo matching BI 705564 fasted (SRD part)	Experimental	Drug: Placebo
Placebo matching BI 705564 fed (SRD part)	Experimental	Drug: Placebo
1 milligram (mg) BI 705564 fasted (SRD part)	Experimental	Drug: BI 705564 (Reference)
3 mg BI 705564 fasted (SRD part)	Experimental	Drug: BI 705564 (Reference)
10 mg BI 705564 fasted (SRD part)	Experimental	Drug: BI 705564 (Reference)
20 mg BI 705564 fasted (SRD part)	Experimental	Drug: BI 705564 (Reference)
40 mg BI 705564 fasted (SRD part)	Experimental	Drug: BI 705564 (Reference)
80 mg BI 705564 fasted (SRD part)	Experimental	Drug: BI 705564 (Reference)
20 mg BI 705564 fed (SRD part)	Experimental	Drug: BI 705564 (Test)
40 mg BI 705564 fed (SRD part)	Experimental	Drug: BI 705564 (Test)
80 mg BI 705564 fed (SRD part)	Experimental	Drug: BI 705564 (Test)
160 mg BI 705564 fed (SRD part)	Experimental	Drug: BI 705564 (Test)
BI 705564 10 mg fasted/ BI 705564 10 mg fed (FE Part)	Experimental	Drug: BI 705564 (Test), Drug: BI 705564 (Reference)
BI 705564 10 mg fed/ BI 705564 10 mg fasted (FE Part)	Experimental	Drug: BI 705564 (Test), Drug: BI 705564 (Reference)

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male subjects according to the assessment of the investigator, 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 50 years (incl.)
Body Mass Index [BMI] of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice [GCP] and local legislation

Key exclusion criteria (28 listed)

-- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140mmHg, 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
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboTablet and solution formulation	Drug	Placebo matching BI 705564 fasted (SRD part), Placebo matching BI 705564 fed (SRD part)
BI 705564 (Test)Fed state	Drug	160 mg BI 705564 fed (SRD part), 20 mg BI 705564 fed (SRD part), 40 mg BI 705564 fed (SRD part), 80 mg BI 705564 fed (SRD part), BI 705564 10 mg fasted/ BI 705564 10 mg fed (FE Part), BI 705564 10 mg fed/ BI 705564 10 mg fasted (FE Part)
BI 705564 (Reference)Fasting state	Drug	1 milligram (mg) BI 705564 fasted (SRD part), 10 mg BI 705564 fasted (SRD part), 20 mg BI 705564 fasted (SRD part), 3 mg BI 705564 fasted (SRD part), 40 mg BI 705564 fasted (SRD part), 80 mg BI 705564 fasted (SRD part), BI 705564 10 mg fasted/ BI 705564 10 mg fed (FE Part), BI 705564 10 mg fed/ BI 705564 10 mg fasted (FE Part)

Primary outcome

Number of Participants With Drug-related Adverse Events (AEs)
Time frame: From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).
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.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part)
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented.
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part)
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part.

3 secondary outcomes

Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part)
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part)
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part)
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.

Results and safety

Results posted to the registry on 6 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Matching BI 705564 Fasted (SRD Part)	12	12
Placebo Matching BI 705564 Fed (SRD Part)	8	8
1 Milligram (mg) BI 705564 Fasted (SRD Part)	6	6
3 mg BI 705564 Fasted (SRD Part)	5	5
10 mg BI 705564 Fasted (SRD Part)	6	6
20 mg BI 705564 Fasted (SRD Part)	6	6
40 mg BI 705564 Fasted (SRD Part)	6	6
80 mg BI 705564 Fasted (SRD Part)	6	6
20 mg BI 705564 Fed (SRD Part)	6	6
40 mg BI 705564 Fed (SRD Part)	6	6
80 mg BI 705564 Fed (SRD Part)	6	6
160 mg BI 705564 Fed (SRD Part)	6	6
BI 705564 10 mg Fasted/ BI 705564 10 mg Fed (FE Part)	6	5
BI 705564 10 mg Fed/BI 705564 10 mg Fasted (FE Part)	6	6

Primary outcome: Number of Participants With Drug-related Adverse Events (AEs)

Time frame: From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).. Count of participants. Unit: Participants

Measure	Placebo Matching BI 705564 Fasted (SRD Part) n = 12	Placebo Matching BI 705564 Fed (SRD Part) n = 8	Placebo Matching BI 705564 Total n = 20	1 Milligram (mg) BI 705564 Fasted (SRD Part) n = 6	3 mg BI 705564 Fasted (SRD Part) n = 5	10 mg BI 705564 Fasted (SRD Part) n = 6	20 mg BI 705564 Fasted (SRD Part) n = 6	40 mg BI 705564 Fasted (SRD Part) n = 6	80 mg BI 705564 Fasted (SRD Part) n = 6	Total BI 705564 Fast (SRD Part) n = 35	20 mg BI 705564 Fed (SRD Part) n = 6	40 mg BI 705564 Fed (SRD Part) n = 6	80 mg BI 705564 Fed (SRD Part) n = 6	160 mg BI 705564 Fed (SRD Part) n = 6	Total BI 705564 Fed (SRD Part) n = 24	Total BI 705564 (SRD Part) n = 59
Value	3	1	4	1	0	0	0	1	1	3	0	4	0	0	4	7

Population analysed: Treated set (TS): TS included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of the investigational treatment.

Primary outcome: Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part)

Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.. Least squares mean (Standard Error). Unit: nanomole*hour/litre [nmol*h/L]

Measure	10 mg BI 705564 Fed (FE Part) n = 11	10 mg BI 705564 Fast (FE Part) n = 12
Value	NA (NA)	NA (NA)

10 mg BI 705564 Fed (FE Part) vs 10 mg BI 705564 Fast (FE Part): Geometric mean (gMean) ratio (%): 158.61 (90% CI 133.679 to 188.195)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability.

Primary outcome: Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part)

Measure	10 mg BI 705564 Fed (FE Part) n = 11	10 mg BI 705564 Fast (FE Part) n = 12
Value	NA (NA)	NA (NA)

10 mg BI 705564 Fed (FE Part) vs 10 mg BI 705564 Fast (FE Part): gMean ratio (%): 194.18 (90% CI 158.912 to 237.267)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Matching BI 705564 Fasted (SRD Part)	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Placebo Matching BI 705564 Fed (SRD Part)	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Placebo Matching BI 705564 Total	0 of 20 (0%)	9 of 20 (45%)	0 of 20
1 Milligram (mg) BI 705564 Fasted (SRD Part)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
3 mg BI 705564 Fasted (SRD Part)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
10 mg BI 705564 Fasted (SRD Part)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
20 mg BI 705564 Fasted (SRD Part)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
40 mg BI 705564 Fasted (SRD Part)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
80 mg BI 705564 Fasted (SRD Part)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Total BI 705564 Fast (SRD Part)	0 of 35 (0%)	12 of 35 (34.3%)	0 of 35
20 mg BI 705564 Fed (SRD Part)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
40 mg BI 705564 Fed (SRD Part)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
80 mg BI 705564 Fed (SRD Part)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
160 mg BI 705564 Fed (SRD Part)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Total BI 705564 Fed (SRD Part)	0 of 24 (0%)	10 of 24 (41.7%)	0 of 24
Total BI 705564 (SRD Part)	0 of 59 (0%)	22 of 59 (37.3%)	0 of 59
10 mg BI 705564 Fast (FE Part)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
10 mg BI 705564 Fed (FE Part)	0 of 11 (0%)	2 of 11 (18.2%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 705564 (Test) and BI 705564 (Reference) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Drug-related Adverse Events (AEs) (time frame: From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.