HealthyPhase 1NCT04789291

A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food

A Phase 1 study testing BI 1595043 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

Completed

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

Trial summary

The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R). 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 1595043
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteBelgium
Study dates: 18 May 2021to 7 Aug 2021
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, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 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, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
Sexually abstinent
Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion

Who cannot join

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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
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)

Show all 9Show 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
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Life Science Services - Clinical Research
Edegem, 2650

Other trials in Belgium

About this study

Official title: A Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 1595043 as Tablets With and Without Food in Healthy Male Subjects

The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).

Conditions: Healthy
Being tested: BI 1595043

What participants receive

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

BI 1595043Drug
Single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet).

Study groups in NCT04789291
Study group	Role	What they receive
BI 1595043 fasted (Reference (R)) / BI 1595043 fed (Test (T))	Experimental	Two period crossover separated by a wash-out of at least 8 days: Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours. Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast. Receives: Drug: BI 1595043
BI 1595043 fed (Test (T)) / BI 1595043 fasted (Reference (R))	Experimental	Two period crossover separated by a wash-out of at least 8 days: Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast. Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours. Receives: Drug: BI 1595043

What is being measured

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

Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Measured: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.
Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)
Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported.
The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Measured: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.

Secondary outcomes (1)

Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Measured: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.

Timeline

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

18 May 20217 Aug 2021

First posted9 Mar 2021
Study start18 May 2021
Primary completion7 Aug 2021
Study completion7 Aug 2021

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: Crossover
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04789291
Sponsor's protocol ID: 1445-0011
Other IDs: 2020-004924-40
Status last verified: Jul 2023
First submitted: 8 Mar 2021
Last updated: 22 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 1595043 as Tablets With and Without Food in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04789291
Acronym / sponsor ID: 1445-0011
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 May 2021 (actual)
Primary completion: 7 Aug 2021 (actual)
Study completion: 7 Aug 2021 (actual)
First posted: 9 Mar 2021 (actual)
Results: Posted 22 Feb 2024

Clinical summary

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

The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 1595043 fasted (Reference (R)) / BI 1595043 fed (Test (T))	Experimental	Drug: BI 1595043Two period crossover separated by a wash-out of at least 8 days: Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours. Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
BI 1595043 fed (Test (T)) / BI 1595043 fasted (Reference (R))	Experimental	Drug: BI 1595043Two period crossover separated by a wash-out of at least 8 days: Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast. Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.

Who may qualify

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

Key inclusion criteria (8 listed)

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), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 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:

Key exclusion criteria (9 listed)

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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed 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
BI 1595043Single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet).	Drug	BI 1595043 fasted (Reference (R)) / BI 1595043 fed (Test (T)), BI 1595043 fed (Test (T)) / BI 1595043 fasted (Reference (R))

Primary outcome

Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.
Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)
Time frame: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.
Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.

1 secondary outcome

Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.

Results and safety

Results posted to the registry on 22 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 1595043 Fasted (Reference (R)) / BI 1595043 Fed (Test (T))	7	7
BI 1595043 Fed (Test (T)) / BI 1595043 Fasted (Reference (R))	6	6

Primary outcome: Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.. Geometric mean (Standard Error). Unit: hour*nanomol/Liter

Measure	BI 1595043 Under Fasted Condition (Reference (R)) n = 13	BI 1595043 Under Fed Condition (T (Test)) n = 13
Value	NA (NA)	NA (NA)

BI 1595043 Under Fasted Condition (Reference (R)) vs BI 1595043 Under Fed Condition (T (Test)): Ratios of adjusted geometric means [%]: 102.76 (90% CI 99.34 to 106.29)

Population analysed: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Primary outcome: Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)

Measure	Reference (R) BI 1595043 Under Fasted Condition n = 13	T (Test) BI 1595043 Under Fed Condition n = 13
Value	NA (NA)	NA (NA)

Reference (R) BI 1595043 Under Fasted Condition vs T (Test) BI 1595043 Under Fed Condition: Ratios of adjusted geometric means [%]: 77.81 (90% CI 69.77 to 86.76)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the day of study drug administration till the next administration or until end of trial, whatever occurred first, up to 14 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1595043 Under Fed Condition (T (Test))	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
BI 1595043 Under Fasted Condition (Reference (R))	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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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 1595043 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

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 8 inclusion and 9 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 22 Feb 2024. 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 Belgium. 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 22 Feb 2024). 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?

Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.). The study lists 2 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 NCT04789291.

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 22 Feb 2024.