A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body

Sponsor
Boehringer Ingelheim
Study ID
NCT07071974
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • BI 456906 formulation A — COMBINATION_PRODUCT
    BI 456906 formulation A
  • BI 456906 formulation B2 — DRUG
    BI 456906 formulation B2

Study Details

The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs. BI 456906 test formulation (Formulation B2).

Key Dates

Start date
Jul 28, 2025
Status verified
Mar 2026
Primary completion
Oct 7, 2025
Completion
Oct 28, 2025

Study Design

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

Arms

  • Experimental: BI 456906 formulation A then BI 456906 formulation B2
    BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment
  • Experimental: BI 456906 formulation B2 then BI 456906 formulation A
    BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment

Primary Outcome Measure

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [ Time Frame: Up to 22 days. ]

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