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

NCT ID: NCT03907280

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2019-12-06

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

T1-T2-R-T3

Group Type: EXPERIMENTAL

BI 1265162 (T1)

Intervention Type: DRUG

oral solution

BI 1265162 (T2)

Intervention Type: DRUG

Solution for inhalation

BI 1265162 (R)

Intervention Type: DRUG

concentrate for i.v. solution

BI 1265162 (T3)

Intervention Type: DRUG

Solution for inhalation

R-T1-T2-T3

Group Type: EXPERIMENTAL

BI 1265162 (T1)

Intervention Type: DRUG

oral solution

BI 1265162 (T2)

Intervention Type: DRUG

Solution for inhalation

BI 1265162 (R)

Intervention Type: DRUG

concentrate for i.v. solution

BI 1265162 (T3)

Intervention Type: DRUG

Solution for inhalation

T2-R-T1-T3

Group Type: EXPERIMENTAL

BI 1265162 (T1)

Intervention Type: DRUG

oral solution

BI 1265162 (T2)

Intervention Type: DRUG

Solution for inhalation

BI 1265162 (R)

Intervention Type: DRUG

concentrate for i.v. solution

BI 1265162 (T3)

Intervention Type: DRUG

Solution for inhalation

Interventions

BI 1265162 (T1)

oral solution

Intervention Type: DRUG

BI 1265162 (T2)

Solution for inhalation

Intervention Type: DRUG

BI 1265162 (R)

concentrate for i.v. solution

Intervention Type: DRUG

BI 1265162 (T3)

Solution for inhalation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33569494 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.mystudywindow.com/

Related Info

Other Identifiers

2018-002689-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1399-0014

Identifier Type: -

Identifier Source: org_study_id