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A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05337592
Collaborator
(none)
79
Enrollment
1
Location
5
Arms
4.2
Anticipated Duration (Months)
18.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses.

Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 1815368 formulation 1
  • Drug: Placebo
  • Drug: BI 1815368 formulation 2
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
This study has 2 parts: a single rising dose (SRD) part and a bioavailability (BA) part. For the SRD part the intervention study model is sequential, while for the BA part the intervention study model is crossover.This study has 2 parts: a single rising dose (SRD) part and a bioavailability (BA) part. For the SRD part the intervention study model is sequential, while for the BA part the intervention study model is crossover.
Masking:
Single (Participant)
Masking Description:
For the Single Rising Dose (SRD) part the participant is blinded. For the bioavailability (BA) part no masking is applicable.
Primary Purpose:
Treatment
Official Title:
A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1815368 Administered as Oral Solution to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Part Investigating Relative Bioavailability of BI 1815368 as Tablet Versus Oral Solution and Tablet With and Without Food in Healthy Male Subjects (BA Part)
Actual Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
Oct 21, 2022
Anticipated Study Completion Date :
Oct 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SRD part: BI 1815368

Drug: BI 1815368 formulation 1
BI 1815368 formulation 1
Placebo Comparator: SRD part: Placebo

Drug: Placebo
Placebo
Experimental: BA part: T1-R-T2

R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition

Drug: BI 1815368 formulation 1
BI 1815368 formulation 1

Drug: BI 1815368 formulation 2
BI 1815368 formulation 2
Experimental: BA part: R-T2-T1

Drug: BI 1815368 formulation 1
BI 1815368 formulation 1

Drug: BI 1815368 formulation 2
BI 1815368 formulation 2
Experimental: BA part: T2-T1-R

Drug: BI 1815368 formulation 1
BI 1815368 formulation 1

Drug: BI 1815368 formulation 2
BI 1815368 formulation 2

Outcome Measures

Primary Outcome Measures

  1. SRD part: Occurrence of any treatment-emergent adverse event [Up to Day 14]

  2. BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Up to Day 5]

  3. BA part: Maximum measured concentration of BI 1815368 in plasma (Cmax) [Up to Day 5]

Secondary Outcome Measures

  1. SRD part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to Day 6]

  2. SRD part: Maximum measured concentration of BI 1815368 in plasma (Cmax) [up to Day 6]

  3. BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [Up to Day 5]

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 in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

  • Any finding in the medical examination (including BP, PR or 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 millimetre of mercury (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 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

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Humanpharmakologisches Zentrum Biberach Biberach Germany 88397

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:
NCT05337592
Other Study ID Numbers:
  • 1485-0001
  • 2021-006856-16
First Posted:
Apr 20, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
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 Aug 11, 2022