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A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05380947
Collaborator
(none)
13
Enrollment
1
Location
4
Arms
2.6
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 1810631 - trial formulation 1 (TF1)
  • Drug: BI 1810631 - new formulation (NF)
  • Drug: Rabeprazole sodium
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
4-way crossover4-way crossover
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Relative Bioavailability of BI 1810631 as Two Different Oral Formulations Given as Single Doses and Investigation of the Effects of Food and Multiple-dose Rabeprazole on the Pharmacokinetics of Single-dose BI 1810631 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Four-way Crossover Trial)
Actual Study Start Date :
Jun 23, 2022
Anticipated Primary Completion Date :
Sep 10, 2022
Anticipated Study Completion Date :
Sep 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment sequence 1: R - T1 - T2 - T3

Treatments: R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole

Drug: BI 1810631 - trial formulation 1 (TF1)
BI 1810631 - trial formulation 1 (TF1)

Drug: BI 1810631 - new formulation (NF)
BI 1810631 - new formulation (NF)

Drug: Rabeprazole sodium
Rabeprazole sodium
Other Names:
  • Pariet®

    		•
    Experimental: Treatment sequence 2: T1 - T3 - R - T2

    Drug: BI 1810631 - trial formulation 1 (TF1)
    BI 1810631 - trial formulation 1 (TF1)

    Drug: BI 1810631 - new formulation (NF)
    BI 1810631 - new formulation (NF)

    Drug: Rabeprazole sodium
    Rabeprazole sodium
    Other Names:
  • Pariet®

    		•
    Experimental: Treatment sequence 3: T2 - R - T3 - T1

    Drug: BI 1810631 - trial formulation 1 (TF1)
    BI 1810631 - trial formulation 1 (TF1)

    Drug: BI 1810631 - new formulation (NF)
    BI 1810631 - new formulation (NF)

    Drug: Rabeprazole sodium
    Rabeprazole sodium
    Other Names:
  • Pariet®

    		•
    Experimental: Treatment sequence 4: T3 - T2 - T1 - R

    Drug: BI 1810631 - trial formulation 1 (TF1)
    BI 1810631 - trial formulation 1 (TF1)

    Drug: BI 1810631 - new formulation (NF)
    BI 1810631 - new formulation (NF)

    Drug: Rabeprazole sodium
    Rabeprazole sodium
    Other Names:
  • Pariet®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to 6 days]

    2. Maximum measured concentration of BI 1810631 in plasma (Cmax) [up to 6 days]

    Secondary Outcome Measures

    1. Area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 6 days]

    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 weight divided by height squared (kg/m2) (inclusive)

    • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

    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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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:
    NCT05380947
    Other Study ID Numbers:
    • 1479-0003
    • 2022-000268-23
    First Posted:
    May 19, 2022
    Last Update Posted:
    Aug 9, 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
    Additional relevant MeSH terms:
    Rabeprazole

    Study Results

    No Results Posted as of Aug 9, 2022