A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: Zongertinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05833139

2022-003757-63 (EudraCT Number)

1479-0004

Details and patient eligibility

About

The main objective of this trial is to investigate the effect of multiple doses of the strong CYP3A inhibitor and recommended P-glycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of zongertinib in plasma following oral administration.

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 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 50 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• 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

• Any finding in the medical examination (including BP, PR or 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(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Zongertinib alone (R) / Zongertinib + itraconazole (T)

Experimental group

Description:

Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2), as reference treatment R. Treatment Period 2: a single oral solution of 200 mg (10 mg/mL in a 20 milliliter (mL) solution) itraconazole was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1 (Day 1, Period 2, Visit 3), 4th day of itraconazole treatment, a single oral dose of 15 mg zongertinib was administered 1 hour (h) after itraconazole administration as test treatment T. The two administrations of zongertinib were separated by a washout interval of at least 14 days. Zongertinib and itraconazole were orally administered with 240 mL of water after an overnight fast of at least 10 h for zongertinib and 9 h for itraconazole.

Treatment:

Drug: Zongertinib

Drug: Itraconazole