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A Study in Healthy Men to Test How BI 456906 is Processed in the Body

NCT ID: NCT05421338

Last Updated: 2022-12-14

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2022-11-17

Brief Summary

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This trial is intended to examine the basic pharmacokinetics of BI 456906 and total \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 456906 (C-14)

Group Type EXPERIMENTAL

BI 456906 (C-14)

Intervention Type DRUG

BI 456906 (C-14)

Interventions

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BI 456906 (C-14)

BI 456906 (C-14)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects with normal Body mass index (BMI) or otherwise healthy male subjects with overweight/obesity 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 65 years (inclusive)
* BMI of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg.
* 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 mmHg, diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 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
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICON

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2021-006690-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1404-0012

Identifier Type: -

Identifier Source: org_study_id