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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05380947

1479-0003

2022-000268-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Treatment sequence 1: R - T1 - T2 - T3

Experimental group

Description:

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

Treatment:

Drug: BI 1810631 - trial formulation 1 (TF1)

Drug: BI 1810631 - new formulation (NF)

Drug: Rabeprazole sodium

Treatment sequence 2: T1 - T3 - R - T2

Experimental group

Treatment:

Drug: BI 1810631 - trial formulation 1 (TF1)

Drug: BI 1810631 - new formulation (NF)

Drug: Rabeprazole sodium

Treatment sequence 3: T2 - R - T3 - T1

Experimental group

Treatment:

Drug: BI 1810631 - trial formulation 1 (TF1)

Drug: BI 1810631 - new formulation (NF)

Drug: Rabeprazole sodium

Treatment sequence 4: T3 - T2 - T1 - R

Experimental group

Treatment:

Drug: BI 1810631 - trial formulation 1 (TF1)

Drug: BI 1810631 - new formulation (NF)

Drug: Rabeprazole sodium