A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03843151
Collaborator
(none)
16
1
1
2.5
6.4

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1358894 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Relative Bioavailability of a Single Oral Dose of BI 1358894 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Fixed Sequence Study)
Actual Study Start Date :
Mar 19, 2019
Actual Primary Completion Date :
Jun 3, 2019
Actual Study Completion Date :
Jun 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: All subjects: Reference followed by Test treatments

Reference - BI 1358894 alone. Test - BI 1358894 + Itraconazole

Drug: BI 1358894
tablet

Drug: Itraconazole
oral solution

Outcome Measures

Primary Outcome Measures

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity [Up to 480 hours.]

  2. Maximum measured concentration of BI 1358894 in plasma [Up to 480 hours.]

Secondary Outcome Measures

  1. Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point [Up to 480 hours.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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 tests

  • Age of 18 to 45 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

  • Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception with their female partner throughout the study and until 1 month after the last administration of trial medication. Adequate methods are:

  • Sexual abstinence or

  • A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or

  • Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner or

  • The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) Unprotected sexual intercourse with a female partner is not allowed throughout the study and until 1 month after the last administration of trial medication.

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 50 to 90 beats per minute (bpm)

  • C-reactive protein (CRP)> Upper limit of normal (ULN), Erythrocyte sedimentation rate (ESR)≥15 millimeters/h, liver or kidney parameter above ULN, or any other 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 medications or their 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)

  • 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 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 in males) 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

  • Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)

  • Any suicidal ideation of type 2 to 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e. active suicidal thought, active suicidal thought with method, active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)

  • Any history of drug-induced liver failure.

  • History of ventricular dysfunction or congestive heart failure.

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 CRS Clinical Research Services Berlin GmbH Berlin Germany 13353

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03843151
Other Study ID Numbers:
  • 1402-0007
  • 2018-004274-10
First Posted:
Feb 15, 2019
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021