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

Sponsor
Boehringer Ingelheim
Study ID
NCT06075277
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • zongertinib — DRUG
    Participants received a single oral dose of 240 mg Zongertinib (4 x 60 mg tablets) in two periods: in Period 1 after an overnight fast of at least 10 hours, and in Period 2 following a high fat/high calorie meal.

Study Details

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.

Key Dates

First listed
Oct 10, 2023
Start date
Oct 19, 2023
Status verified
Sep 2025
Primary completion
Jan 2, 2024
Completion
Jan 2, 2024

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: BI 1810631 (iCF) fed state (Reference, R) then fasting state (Test, T)
    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.
  • Experimental: BI 1810631 (iCF) fasting state (Test, T) then fed state (Reference, R)
    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.

Primary Outcome Measure

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: Within 3 hours before Zongertinib administration, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours following administration. ]

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