A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
- Registration Number
- NCT06070610
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 14
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 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 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)
- 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 (including severe renal or hepatic impairment)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pirfenidone + nintedanib (R) then BI 1015550 + pirfenidone+ nintedanib (T) BI 1015550 Reference Treatment (R) Test Treatment (T) Pirfenidone + nintedanib (R) then BI 1015550 + pirfenidone+ nintedanib (T) Pirfenidone Reference Treatment (R) Test Treatment (T) Pirfenidone + nintedanib (R) then BI 1015550 + pirfenidone+ nintedanib (T) Nintedanib Reference Treatment (R) Test Treatment (T)
- Primary Outcome Measures
Name Time Method Maximum measured concentration of nintedanib in plasma (Cmax) up to 4 days from nintedanib administration 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 Maximum measured concentration of pirfenidone in plasma (Cmax) up to 24 hours from pirfenidone administration 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 Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) up to 24 hours from pirfenidone administration Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) up to 4 days from nintedanib administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany