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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-06-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment sequence R-T2-T1

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

Group Type EXPERIMENTAL

BI 456906 - Formulation A

Intervention Type DRUG

Formulation A

BI 456906 - Formulation B

Intervention Type DRUG

Formulation B

BI 456906 - Formulation C

Intervention Type DRUG

Formulation C

Treatment sequence T1-R-T2

Group Type EXPERIMENTAL

BI 456906 - Formulation A

Intervention Type DRUG

Formulation A

BI 456906 - Formulation B

Intervention Type DRUG

Formulation B

BI 456906 - Formulation C

Intervention Type DRUG

Formulation C

Treatment sequence T2-T1-R

Group Type EXPERIMENTAL

BI 456906 - Formulation A

Intervention Type DRUG

Formulation A

BI 456906 - Formulation B

Intervention Type DRUG

Formulation B

BI 456906 - Formulation C

Intervention Type DRUG

Formulation C

Interventions

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BI 456906 - Formulation A

Formulation A

Intervention Type DRUG

BI 456906 - Formulation B

Formulation B

Intervention Type DRUG

BI 456906 - Formulation C

Formulation C

Intervention Type DRUG

Other Intervention Names

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Survodutide Survodutide Survodutide

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes