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A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT03892616
Collaborator
(none)
24
Enrollment
1
Location
12
Arms
2.8
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1) of BI 1358894 under fed conditions following oral administration and to investigate the effect of food on the exposure with TF2 (TF2a, TF2b).

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 1358894 (B)
  • Drug: BI 1358894 (C)
  • Drug: BI 1358894 (D)
  • Drug: BI 1358894 (E)
  • Drug: BI 1358894 (A)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Relative Bioavailability and Food Effect of a Single Dose of Different Solid Formulations of BI 1358894 Compared to a Single Dose of the Reference Tablet Formulation of BI 1358894 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male Subjects (an Open-label, Single-dose, Randomised, Incomplete Blocks Crossover Design Study)
Actual Study Start Date :
Apr 8, 2019
Actual Primary Completion Date :
Jul 3, 2019
Actual Study Completion Date :
Jul 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: A - B - C

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: D - A - B

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: E - B - A

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: C - A - D

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: A - E - C

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: E - D - A

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: B - C - D

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed
Experimental: C - E - B

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted
Experimental: B - D - E

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted
Experimental: D - C - E

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted
Experimental: C - B - A

Drug: BI 1358894 (B)
Tablet formulation 2 (TF2a), fed

Drug: BI 1358894 (C)
Tablet formulation 2 (TF2a), fasted

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed
Experimental: A - E - D

Drug: BI 1358894 (D)
Tablet formulation 2 (TF2b), fed

Drug: BI 1358894 (E)
Tablet formulation 2 (TF2b), fasted

Drug: BI 1358894 (A)
Tablet formulation 1 (TF1), fed

Outcome Measures

Primary Outcome Measures

  1. Maximum measured concentration of BI 1358894 in plasma (Cmax) [Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h,4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.]

    Maximum measured concentration of BI 1358894 in plasma (Cmax).

  2. Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h,4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.]

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).

Secondary Outcome Measures

  1. Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h,4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 240h, 312h after drug administration in each treatment period.]

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

  2. Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 72 hours (AUC0-72) [Within 2 hours (h) before and at 10 minutes (min), 20min, 30min, 1h, 1h30min, 2h, 3h,4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration in each treatment period.]

    Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 72 hours (AUC0-72).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 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 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

  • 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 of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device (IUD) that started at least 2 months prior to first study drug administration, or barrier method (e.g. diaphragm with spermicide)

  • Sexually abstinent

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

  • Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy)

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 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 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 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

  • 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 Suicidal 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CRS Clinical Research Services Mannheim GmbH Mannheim Germany 68167

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:
NCT03892616
Other Study ID Numbers:
  • 1402-0010
  • 2018-003603-19
First Posted:
Mar 27, 2019
Last Update Posted:
Nov 11, 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

Study Results

No Results Posted as of Nov 11, 2021