Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05515328
Other study ID # 1366-0008
Secondary ID 2022-001549-19
Status Completed
Phase Phase 1
First received
Last updated
Start date September 8, 2022
Est. completion date November 17, 2022

Study information

Verified date November 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 17, 2022
Est. primary completion date November 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
[¹4C] BI 685509 formulation 1
[¹4C] BI 685509 formulation 1
[¹4C] BI 685509 formulation 2
[¹4C] BI 685509 formulation 2
BI 685509 formulation 3
BI 685509 formulation 3

Locations

Country Name City State
Netherlands ICON Groningen

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) up to 14 days
Primary 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) up to 14 days
Primary Part B: Absolute bioavailability of BI 685509 (%, obtained from a ratio of dose normalised values of AUCo-8 after [¹4C] BI 685509 formulation 2 and BI 685509 formulation 3 administration) AUCo-8: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity up to 4 days
Secondary 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) up to 14 days
Secondary Part A: Maximum measured concentration of the analyte in plasma (C???) up to 14 days
Secondary 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) up to 4 days
Secondary 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 (AUC0-8) up to 4 days
Secondary Part B: Maximum measured concentration of [¹4C] BI 685509 formulation 2 and BI 685509 formulation 3 in plasma (C???) up to 4 days
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Completed NCT04052711 - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design Phase 1

External Links