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

Boehringer Ingelheim14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BI 1015550DRUG

BI 1015550

NintedanibDRUG

Soft capsules

PirfenidoneDRUG

Film-coated tablets

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Humanpharmakologisches Zentrum Biberach

Biberach, Germany

Outcomes

Primary Outcomes

Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.

Time frame: At 0, 0:30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from pirfenidone administration (Period 1) and at 0, 0.30, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 24 hours from nerandomilast and pirfenidone administration (Period 2)

Area Under the Concentration-time Curve of Pirfenidone in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

Area under the concentration-time curve of pirfenidone in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.

Maximum Measured Concentration of Pirfenidone in Plasma (Cmax)

Maximum measured concentration of pirfenidone in plasma (Cmax). Geometric least squares mean (adjusted geometric mean) and the standard error (actually adjusted geometric standard error) were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.

Data from ClinicalTrials.gov

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