A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body

Sponsor
Boehringer Ingelheim
Study ID
NCT06393127
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Nerandomilast — DRUG
    One dose of Formulation C2 (Test treatment - T) administered with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.
  • Nerandomilast — DRUG
    One dose of Formulation C1 - phase 3 formulation (Reference treatment - R) administered with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.

Study Details

The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.

Key Dates

Start date
Jun 4, 2024
Status verified
Oct 2025
Primary completion
Sep 10, 2024
Completion
Sep 10, 2024

Study Design

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

Arms

  • Experimental: Test treatment (T), then reference treatment (R): T-R
    Healthy subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). Both treatments were administered orally with approximately 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After drug administration, subjects additionally fasted for 4 h.
  • Experimental: Reference treatment (R), then test treatment (T): R-T
    Healthy subjects were administered one tablet of nerandomilast (Formulation C1 - phase 3 formulation) (Reference treatment - R). After a washout period of at least 10 days, subjects were administered one tablet of nerandomilast (Formulation C2) (Test treatment - T). Both treatments were administered orally with approximately 240 mL of water after an overnight fast of at least 10 h. After drug administration, subjects additionally fasted for 4 h.

Primary Outcome Measure

Area Under the Concentration-time Curve of Nerandomilast in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) [ Time Frame: Within 3 h prior to drug administration, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 34, 48, 58, 72, 96, 120, 144 h after drug administration. ]

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