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

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05380947
• Other study ID #: 1479-0003
• Secondary ID: 2022-000268-23
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2022
• Est. completion date: September 13, 2022

Study information

• Verified date: September 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1810631 - trial formulation 1 (TF1)
BI 1810631 - trial formulation 1 (TF1)
• BI 1810631 - new formulation (NF)
BI 1810631 - new formulation (NF)
• Rabeprazole sodium
Rabeprazole sodium

Locations

Country	Name	City	State
Germany	Humanpharmakologisches Zentrum Biberach	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum measured concentration of BI 1810631 in plasma (Cmax)		up to 6 days
Secondary	Area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 6 days

External Links

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