A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body

Healthy Clinical Trial

Official title:

A Phase I, Open-label Trial to Investigate Metabolism and Pharmacokinetics of a Single Dose of [14C] BI 1358894 Administered as Oral Solution (Part 1) and Multiple Doses of BI 1358894 Administered as Film-coated Tablets (Part 2) in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567316
• Other study ID #: 1402-0015
• Secondary ID: 2020-002054-25
• Status: Completed
• Phase: Phase 1
• Start date: October 19, 2020
• Est. completion date: January 10, 2021

Study information

• Verified date: January 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites, total radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of [14C] BI 1358894 in Part 1 and to investigate the pharmacokinetics of BI 1358894 and its metabolite(s) following multiple-dose treatment over 21 days with non- radiolabelled compound of BI 1358894 in Part 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 10, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 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 (BP, PR), 12-lead ECG, and clinical laboratory tests

• Age of 18 to 65 years (inclusive)

• BMI of 18.5 to 29.9 kg/m2 (inclusive)

• Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

• Male subjects who meet any of the following criteria from screening until 90 days after trial completion:

• Use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least two months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or,

• Sexually abstinent or,

• A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or,

• Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion, or bilateral oophorectomy) or,

• Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of follicle-stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 50 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

• C-reactive protein (CRP) > upper limit of normal (ULN), liver or kidney parameter above ULN

• 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

• For Part 1 only:

• Participation in another absorption, distribution, metabolism, and excretion (ADME) pharmacokinetics study with a radiation burden of >0.1 millisievert (mSv) in the period of 1 year prior to screening

• Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)) in the period of 1 year prior to screening

• Irregular defecation pattern (less than a mean of one bowel movement every 1 or 2 days)

In addition, the following Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) specific exclusion criterion apply:

• A positive test indicating an ongoing infection with SARS-CoV-2 and clinical symptoms suggestive of the disease

• Further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [14C]-radiolabelled BI 1358894
Part 1
• BI 1358894
Part 2

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences Onderzoekscentrum Martini	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance recoveries of [14C] BI 1358894 total radioactivity in urine and faeces after single oral dose		Up to Day 50
Primary	Amount of radioactivity excreted as a percentage of the administered dose (fe0-t2) for urine and faeces		Up to Day 50
Secondary	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)	part 1	Up to Day 50
Secondary	Maximum measured concentration of the analyte in plasma (Cmax)	part 1	Up to Day 50
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 (AUC0-24)	part 2	Up to Day 62
Secondary	Maximum measured concentration of the analyte in plasma (Cmax)	part 2	Up to Day 62
Secondary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)	part 2	Up to Day 62
Secondary	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t (Cmax,ss)	part 2	Up to Day 62

External Links

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