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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05421338
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
2.6
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 456906 (C-14)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 456906 (C-14) Administered Subcutaneously to (Otherwise) Healthy Male Volunteers With Normal Body Weight, Overweight or Obesity
Actual Study Start Date :
Jul 4, 2022
Anticipated Primary Completion Date :
Sep 22, 2022
Anticipated Study Completion Date :
Sep 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 456906 (C-14)

Drug: BI 456906 (C-14)
BI 456906 (C-14)

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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 Outcome Measures

  1. Maximum measured concentration of the analyte (Cmax) [up to 22 days]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

  • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ICON Groningen Netherlands 9728 NZ

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05421338
Other Study ID Numbers:
  • 1404-0012
  • 2021-006690-28
First Posted:
Jun 16, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 10, 2022