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This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men

This study is not yet open for participant recruitment.
Verified October 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT03349723
First Posted: November 21, 2017
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose

The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of single rising doses.

Secondary objective is the exploration of the pharmacokinetics (PK) of BI 1265162 after single dosing.


Condition Intervention Phase
Healthy Drug: BI 1265162 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 1265162 in Healthy Male Volunteers in a Partially Randomised, Single Blind, Placebo-controlled Trial

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number [N (%)] of subjects with drug-related adverse events [ Time Frame: Up to 9 days ]

Secondary Outcome Measures:
  • AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: Up to 48 hours ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Up to 48 hours ]

Estimated Enrollment: 56
Anticipated Study Start Date: December 6, 2017
Estimated Study Completion Date: February 26, 2018
Estimated Primary Completion Date: February 26, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1265162
BI 1265162
Drug: BI 1265162
Single rising dose groups
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Single rising dose groups

Detailed Description:
To investigate safety, tolerability and pharmacokinetics of BI 1265162 in man.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.)
  • Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) of equal or greater than 80% of predicted normal, at screening and prior to randomisation
  • 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 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 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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 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)
  • 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
  • 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 30 g per day for males)
  • 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 trial site
  • A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant 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)
  • A history of chronic kidney disease (EGFR <59 mls/min including corrections as per ethnicity)
  • 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
  • The subject has a diagnosis history of pulmonary hyperreactivity
  • Male subjects with woman of child bearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 14 days after last administration of trial medication (BI 1265162 or placebo)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349723


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03349723     History of Changes
Other Study ID Numbers: 1399-0001
2017-001106-15 ( EudraCT Number )
First Submitted: November 17, 2017
First Posted: November 21, 2017
Last Update Posted: November 21, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No