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

Sponsor
Boehringer Ingelheim
Study ID
NCT05833139
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Zongertinib — DRUG
    Zongertinib
  • Itraconazole — DRUG
    Itraconazole

Study Details

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.

Key Dates

First listed
Apr 27, 2023
Start date
Apr 14, 2023
Status verified
Sep 2025
Primary completion
Jun 12, 2023
Completion
Jun 12, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zongertinib alone (R) / Zongertinib + itraconazole (T)
    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.

Primary Outcome Measure

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) [ Time Frame: Within 3 hours (h) prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 47, 71, 119, 167 h for both periods, and additionally at 191, 215, 239, 263, and 287 h for period 2, after zongertinib administration. ]

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