A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

Healthy Clinical Trial

Official title:

The Effect of Multiple Oral Doses of Bosentan on the Steady State Kinetics of BI 425809 After Oral Administration to Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723874
• Other study ID #: 1346-0056
• Secondary ID: 2021-006676-17
• Status: Completed
• Phase: Phase 1
• Start date: March 6, 2023
• Est. completion date: May 26, 2023

Study information

• Verified date: June 2023
• 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 relative bioavailability of BI 425809 given alone (Reference) compared to a combined administration with the moderate CYP3A4 inducer bosentan (Test) following repeated oral administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 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 30 to 55 years (inclusive)

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

• 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 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 45 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 425809
BI 425809
• bosentan
bosentan

Locations

Country	Name	City	State
Germany	Humanpharmakologisches Zentrum Biberach	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)		On Day 10 of period 1 and on Day 14 of period 2.
Primary	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t (Cmax,ss)		On Day 10 of period 1 and on Day 14 of period 2.
Secondary	Minimum concentration of the analyte in plasma at steady state within a uniform dosing interval t (Cmin,ss)		On Day 10 of period 1 and on Day 14 of period 2.

External Links

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