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

NCT05421338 | Completed Phase 1

• 2 other identifiers: 1404-00122021-006690-28
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_urine, 0-tz)

  up to 7 weeks

• Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe_faeces, 0-tz)

  up to 7 weeks

Secondary Outcomes (2)

• Maximum measured concentration of the analyte (Cmax)

  up to 22 days

• Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz)

  up to 22 days

Study Arms (1)

BI 456906 (C-14)

EXPERIMENTAL

Drug: BI 456906 (C-14)

Interventions

BI 456906 (C-14) DRUG

BI 456906 (C-14)

BI 456906 (C-14)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON

Groningen, 9728 NZ, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 456906; Carbon-14

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: July 4, 2022
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)