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A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06070610
Collaborator
(none)
14
Enrollment
1
Arm
1.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The main objective of this trial is to investigate the induction effect of multiple oral doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Crossover Assignment
Intervention Model Description:
Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Multiple Oral Doses of BI 1015550 on the Pharmacokinetics of Nintedanib and Pirfenidone Administered Single Dose to Healthy Male Subjects (Open-label, Two-period, Fixed-sequence Crossover Trial)
Anticipated Study Start Date :
Nov 8, 2023
Anticipated Primary Completion Date :
Dec 14, 2023
Anticipated Study Completion Date :
Dec 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pirfenidone + nintedanib (R) then BI 1015550 + pirfenidone+ nintedanib (T)

Reference Treatment (R) Test Treatment (T)

Drug: BI 1015550
BI 1015550

Drug: Nintedanib
Soft capsules
Other Names:
  • Ofev®

    • Drug: Pirfenidone
    Film-coated tablets
    Other Names:
  • Esbriet®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to 4 days from nintedanib administration]

    2. Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 4 days from nintedanib administration]

    3. Maximum measured concentration of nintedanib in plasma (Cmax) [up to 4 days from nintedanib administration]

    4. Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to 24 hours from pirfenidone administration]

    5. Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) [up to 24 hours from pirfenidone administration]

    6. Maximum measured concentration of pirfenidone in plasma (Cmax) [up to 24 hours from pirfenidone administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. 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

    2. Age of 18 to 55 years (inclusive)

    3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

    4. 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:

    1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

    2. 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)

    3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

    4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

    5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (including severe renal or hepatic impairment)

    6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

    7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

    8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT06070610
    Other Study ID Numbers:
    • 1305-0034
    • 2023-505522-34-00
    • U1111-1292-0376
    First Posted:
    Oct 6, 2023
    Last Update Posted:
    Oct 6, 2023
    Last Verified:
    Sep 1, 2023
    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:
    Pirfenidone
    Nintedanib

    Study Results

    No Results Posted as of Oct 6, 2023