Current partner codePEPTIDESDE
NCT05421338·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

6

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

BI 456906 (C-14)

BI 456906 (C-14)

Timeline

From registration to results.

  1. First posted

    Jun 16, 2022

  2. Study start

    Jul 4, 2022

  3. Primary completion

    Nov 17, 2022

  4. Study completion

    Nov 17, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Dec 14, 2022

Outcomes

What the study measures.

Primary outcomes

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)

Time frame · 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)

Time frame · up to 7 weeks

Secondary outcomes

Maximum measured concentration of the analyte (Cmax)

Time frame · 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)

Time frame · up to 22 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
MALE
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.

Study locations

1 registered sites.

Netherlands. Showing up to 24 locations stored in the fast local snapshot.

ICON

Groningen, Netherlands

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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