A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body

Sponsor
Boehringer Ingelheim
Study ID
NCT06494761
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • zongertinib — DRUG
    Participants received 120 mg Zongertinib daily as two 60 mg tablets.
  • midazolam — DRUG
    Participants received 1 mg Midazolam as 0.5 mL oral solution.
  • omeprazole — DRUG
    Participants received 20 mg Omeprazole.
  • repaglinide — DRUG
    Participants received a 0.5 mg Repaglinide.

Study Details

The main objective of this trial is to assess the effect of multiple oral doses of zongertinib on the pharmacokinetics of midazolam, omeprazole and repaglinide.

Key Dates

First listed
Jul 10, 2024
Start date
Jul 30, 2024
Status verified
Nov 2025
Primary completion
Oct 16, 2024
Completion
Oct 16, 2024

Study Design

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

Arms

  • Experimental: Repaglinide+Midazolam+Omeprazole (Reference)/ Zongertinib+Repaglinide+Midazolam+Omeprazole (Test)
    Reference (Repaglinide + Midazolam + Omeprazole) In the reference treatment period (Period 1), participants received 0.5 mg repaglinide tablet (Day 1, after ≥10 h fast; Reference Treatment 1). On Day 2, they received 1 mg midazolam (0.5 mL oral solution) with 20 mg omeprazole tablet under the same fasting conditions (Reference Treatment 2). Test (Zongertinib + Repaglinide + Midazolam + Omeprazole) In the test treatment period (Period 2), participants received multiple once-daily doses of 120 mg zongertinib from Day 1 to Day 15. A single 0.5 mg repaglinide tablet was co-administered on Day 1 (Test Treatment 1) and Day 14 (Test Treatment 3), and a single dose of the probe drug cocktail containing 1 mg midazolam (0.5 mL oral solution) and 20 mg omeprazole tablet was co-administered on Day 2 (Test Treatment 2) and Day 15 (Test Treatment 4).

Primary Outcome Measure

Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC₀-∞) [ Time Frame: Samples were collected on Day 1 (Period 1), Day 1 (Period 2), and Day 14 (Period 2). See endpoint description for the full sampling schedule ]

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