A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood

Healthy Clinical Trial

Official title:

The Effect of Multiple Oral Doses of BI 1015550 on the Pharmacokinetics of Nintedanib and Pirfenidone Administered Single Dose to Healthy Male Subjects (Open-label, Two-period, Fixed-sequence Crossover Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06070610
• Other study ID #: 1305-0034
• Secondary ID: 2023-505522-34-0
• Status: Completed
• Phase: Phase 1
• Start date: November 8, 2023
• Est. completion date: December 14, 2023

Study information

• Verified date: December 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 induction effect of multiple oral doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. 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

2. Age of 18 to 55 years (inclusive)

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

4. 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:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

2. 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 45 to 90 beats per minute (bpm)

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (including severe renal or hepatic impairment)

6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1015550
BI 1015550
• Nintedanib
Soft capsules
• Pirfenidone
Film-coated tablets

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 nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to 4 days from nintedanib administration
Primary	Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 4 days from nintedanib administration
Primary	Maximum measured concentration of nintedanib in plasma (Cmax)		up to 4 days from nintedanib administration
Primary	Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to 24 hours from pirfenidone administration
Primary	Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		up to 24 hours from pirfenidone administration
Primary	Maximum measured concentration of pirfenidone in plasma (Cmax)		up to 24 hours from pirfenidone administration

External Links

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