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Completed

NCT Number: NCT05515328

A Study in Healthy Men to Test How BI 685509 is Processed in the Body

The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects.

The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male 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 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
  • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Male subjects with women of child-bearing potential (WOCBP) partner who are vasectomised or willing to use male contraception (condom or sexual abstinence) from time point of study drug administration until 15 weeks thereafter

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 of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 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
  • 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

Treatment and study plan

[¹⁴C] BI 685509 formulation 1

Drug

[¹⁴C] BI 685509 formulation 1

[¹⁴C] BI 685509 formulation 2

Drug

[¹⁴C] BI 685509 formulation 2

BI 685509 formulation 3

Drug

BI 685509 formulation 3

Primary outcomes

  1. Part A: fraction of [¹⁴C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz)

    Time frame: up to 14 days

  2. Part A: fraction of [¹⁴C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces,0-tz)

    Time frame: up to 14 days

  3. Part B: Absolute bioavailability of BI 685509 (%, obtained from a ratio of dose normalised values of AUCo-∞ after [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 administration)

    Time frame: up to 4 days

    AUCo-∞: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

Secondary outcomes

  1. Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC₀-tz)

    Time frame: up to 14 days

  2. Part A: Maximum measured concentration of the analyte in plasma (Cₘₐₓ)

    Time frame: up to 14 days

  3. Part B: Area under the concentration-time curve of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma over the time interval from 0 to the last quantifiable time point (AUC₀-tz)

    Time frame: up to 4 days

  4. Part B: Area under the concentration-time curve of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma over the time interval from 0 extrapolated to infinity (AUC₀-∞)

    Time frame: up to 4 days

  5. Part B: Maximum measured concentration of [¹⁴C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma (Cₘₐₓ)

    Time frame: up to 4 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Investigation of Metabolism and Pharmacokinetics and Absolute Bioavailability of BI 685509 (C-14) After Intravenous and Oral Administration in Healthy Male Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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