A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 456906 - Formulation C; Drug: BI 456906 - Formulation B; Drug: BI 456906 - Formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06772532

U1111-1310-7283 (Registry Identifier)

2024-516529-30-00 (Registry Identifier)

1404-0074

Details and patient eligibility

About

The main objective of this trial is to investigate relative bioavailability of BI 456906 formulation B and BI 456906 formulation C vs. BI 456906 formulation A.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
• Age of 18 to 55 years (inclusive).
• Body mass index (BMI) of 20 to 29.9 kg/m² (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

Further inclusion criteria apply.

Exclusion criteria

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm).
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator.

Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Treatment sequence R-T2-T1

Experimental group

Description:

T1: BI 456906 formulation B T2: BI 456906 formulation C R: BI 456906 formulation A

Treatment:

Drug: BI 456906 - Formulation A

Drug: BI 456906 - Formulation B

Drug: BI 456906 - Formulation C

Treatment sequence T1-R-T2

Experimental group

Treatment:

Drug: BI 456906 - Formulation A

Drug: BI 456906 - Formulation B

Drug: BI 456906 - Formulation C

Treatment sequence T2-T1-R

Experimental group

Treatment:

Drug: BI 456906 - Formulation A

Drug: BI 456906 - Formulation B

Drug: BI 456906 - Formulation C