A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: zongertinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06075277

1479-0010

2022-502860-19-00 (Other Identifier)

U1111-1291-3312 (Registry Identifier)

Details and patient eligibility

About

The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 ICH-GCP and local legislation prior to admission to the trial

Exclusion criteria

1. 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
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

BI 1810631 (iCF) fed state (Reference, R) then fasting state (Test, T)

Experimental group

Description:

Period 1: Participants received a single oral dose of 240 milligram (mg) Zongertinib as film coated tablets (4x 60 mg tablet) following a high fat/high calorie meal. Period 2: Participants received a single oral dose of 240 milligram (mg) of Zongertinib as film coated tablets (4x 60 mg tablets) following an overnight fast of at least 10 hours.

Treatment:

Drug: zongertinib

BI 1810631 (iCF) fasting state (Test, T) then fed state (Reference, R)

Experimental group

Description:

Period 1: Participants received a single oral dose of 240 milligram (mg) of Zongertinib as film coated tablets (4x 60 mg tablets) following an overnight fast of at least 10 hours. Period 2: Participants received a single oral dose of 240 milligram (mg) Zongertinib as film coated tablets (4x 60 mg tablet) following a high fat/high calorie meal.

Treatment:

Drug: zongertinib