HealthyPhase 1NCT03907280

A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood

A Phase 1 study testing BI 1265162 (T1), BI 1265162 (T2) and BI 1265162 (R) 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

The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat. 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 1265162 (T1), BI 1265162 (T2) and BI 1265162 (R)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteGermany
Study dates: 23 Apr 2019to 6 Dec 2019
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)), 12-lead Electrocardiogram (ECG), and clinical laboratory
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 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)) 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 45 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 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 25Show 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 of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
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 of planned administration of trial medication or intended blood donation during the trial
Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
Inability to comply with the 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 ECG finding at screening
A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
The subject has a diagnosis history of pulmonary hyperreactivity
A history of chronic kidney disease
Cannot use Respimat® appropriately

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: Absolute Bioavailability of BI 1265162 Following Oral and Inhaled Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study Followed by a Fixed Treatment)

The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.

Conditions: Healthy
Being tested: BI 1265162 (T1), BI 1265162 (T2), BI 1265162 (R), BI 1265162 (T3)

What participants receive

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

BI 1265162 (T1)Drug
oral solution
BI 1265162 (T2)Drug
Solution for inhalation
BI 1265162 (R)Drug
concentrate for i.v. solution
BI 1265162 (T3)Drug
Solution for inhalation

Study groups in NCT03907280
Study group	Role	What they receive
T1-T2-R-T3	Experimental	Not described Receives: Drug: BI 1265162 (T1); Drug: BI 1265162 (T2); Drug: BI 1265162 (R); Drug: BI 1265162 (T3)
R-T1-T2-T3	Experimental	Not described Receives: Drug: BI 1265162 (T1); Drug: BI 1265162 (T2); Drug: BI 1265162 (R); Drug: BI 1265162 (T3)
T2-R-T1-T3	Experimental	Not described Receives: Drug: BI 1265162 (T1); Drug: BI 1265162 (T2); Drug: BI 1265162 (R); Drug: BI 1265162 (T3)

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 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)
Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm).
Time frame for treatment T1:
Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug.
Time frame for treatment T2 and T3:
Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug.
Time frame for treatment R:
Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.
Measured: Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.

Timeline

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

23 Apr 20196 Dec 2019

First posted8 Apr 2019
Study start23 Apr 2019
Primary completion6 Dec 2019
Study completion6 Dec 2019

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.
Publications (1)Papers the sponsor has linked to this study.
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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03907280
Sponsor's protocol ID: 1399-0014
Other IDs: 2018-002689-38, 2018
Status last verified: Mar 2022
First submitted: 5 Apr 2019
Last updated: 6 Jul 2022
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: http://trials.boehringer-ingelheim.com/

Publications

Mackie A, Rascher J, Schmid M, Endriss V, Brand T, Seibold W. First clinical trials of the inhaled epithelial sodium channel inhibitor BI 1265162 in healthy volunteers. ERJ Open Res. 2021 Feb 1;7(1):00447-2020. doi: 10.1183/23120541.00447-2020. eCollection 2021 Jan.
PubMed 33569494

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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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: Absolute Bioavailability of BI 1265162 Following Oral and Inhaled Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Three-period, Three-sequence Crossover Study Followed by a Fixed Treatment)
ClinicalTrials.gov ID: NCT03907280
Acronym / sponsor ID: 1399-0014
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 23 Apr 2019 (actual)
Primary completion: 6 Dec 2019 (actual)
Study completion: 6 Dec 2019 (actual)
First posted: 8 Apr 2019 (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.

The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
T1-T2-R-T3	Experimental	Drug: BI 1265162 (T1), Drug: BI 1265162 (T2), Drug: BI 1265162 (R), Drug: BI 1265162 (T3)
R-T1-T2-T3	Experimental	Drug: BI 1265162 (T1), Drug: BI 1265162 (T2), Drug: BI 1265162 (R), Drug: BI 1265162 (T3)
T2-R-T1-T3	Experimental	Drug: BI 1265162 (T1), Drug: BI 1265162 (T2), Drug: BI 1265162 (R), Drug: BI 1265162 (T3)

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, 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
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 Good Clinical Practice (GCP) and local legislation

Key exclusion criteria (25 listed)

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 45 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 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 1265162 (T1)oral solution	Drug	R-T1-T2-T3, T1-T2-R-T3, T2-R-T1-T3
BI 1265162 (T2)Solution for inhalation	Drug	R-T1-T2-T3, T1-T2-R-T3, T2-R-T1-T3
BI 1265162 (R)concentrate for i.v. solution	Drug	R-T1-T2-T3, T1-T2-R-T3, T2-R-T1-T3
BI 1265162 (T3)Solution for inhalation	Drug	R-T1-T2-T3, T1-T2-R-T3, T2-R-T1-T3

Primary outcome

Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)
Time frame: Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.
Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm). Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug. Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug. Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.

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
(T1-T2-R-T3) Treatment Sequence	4	4
(R-T1-T2-T3) Treatment Sequence	4	4
(T2-R-T1-T3) Treatment Sequence	4	4

Primary outcome: Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)

Time frame: Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.. Geometric least squares mean (Standard Error). Unit: ((hour * millimole) / liter) / kilogram

Measure	BI 1265162 as Infusion (R) n = 12	BI 1265162 as Oral Solution (T1) n = 12	BI 1265162 for Inhalation With Activated Charcoal (T2) n = 11	BI 1265162 for Inhalation Without Activated Charcoal (T3) n = 12
Value	44.63 (NA)	0.22 (NA)	17.97 (NA)	17.96 (NA)

BI 1265162 as Infusion (R) vs BI 1265162 as Oral Solution (T1): Ratio of the geometric means (T1/R) [%]: 0.5 (90% CI 0.39 to 0.63), Mixed Models Analysis
BI 1265162 as Infusion (R) vs BI 1265162 for Inhalation With Activated Charcoal (T2): Ratio of the geometric means (T2/R) [%]: 40.26 (90% CI 31.68 to 51.15), Mixed Models Analysis
BI 1265162 as Infusion (R) vs BI 1265162 for Inhalation Without Activated Charcoal (T3): Ratio of the geometric means (T3/R) [%]: 40.24 (90% CI 31.86 to 50.83), Mixed Models Analysis

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): All participants who were randomized and treated with at least 1 dose of any trial drug and who provided at least 1 PK endpoint being defined as primary or further and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Adverse events

Time frame: For Serious and Other Adverse Events: On-treatment period, that is, from administration of the respective formulation of BI 1265162 until the end of the residual effect period, up to 2 days. For All-Cause Mortality: Each on-treatment period + Follow-up period, i.e. up to 48 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1265162 as Infusion (R)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
BI 1265162 as Oral Solution (T1)	1 of 12 (8.3%)	2 of 12 (16.7%)	0 of 12
BI 1265162 for Inhalation With Activated Charcoal (T2)	0 of 11 (0%)	0 of 11 (0%)	0 of 11
BI 1265162 for Inhalation Without Activated Charcoal (T3)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

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.
Derived from this study: PubMed 33569494Mackie A, Rascher J, Schmid M, Endriss V, Brand T, Seibold W. First clinical trials of the inhaled epithelial sodium channel inhibitor BI 1265162 in healthy volunteers. ERJ Open Res. 2021 Feb 1;7(1):00447-2020. doi: 10.1183/23120541.00447-2020. eCollection 2021 Jan.
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: http://trials.boehringer-ingelheim.com/

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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 1265162 (T1), BI 1265162 (T2) and BI 1265162 (R) 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 25 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?

Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm) (time frame: Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.). 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 NCT03907280, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 1 Nov 2026.