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

NCT06070610 | Completed Phase 1 Results

• 3 other identifiers: 1305-00342023-505522-34-00U1111-1292-0376
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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)

• 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.

  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 Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of nintedanib 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.

  At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2)

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

  Area under the concentration-time curve of nintedanib 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.

  At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2)

• Maximum Measured Concentration of Nintedanib in Plasma (Cmax)

  Maximum measured concentration of nintedanib 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.

  At 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from pirfenidone administration (Period 1) and at 24, 24:30, 25, 25:30, 26, 27, 28, 30, 32, 34, 36, 48, 60,72, 96 hours from nerandomilast and pirfenidone administration (Period 2)

Study Arms (1)

Reference treatment/Test treatment

EXPERIMENTAL

In the reference (R) treatment (period 1, two days of treatment), a single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib on Day 2. In the test (T) treatment (period 2, ten days of treatment), 18 mg nerandomilast were administered twice daily for 10 days (Day -6 to Day 4). A single dose of 267 mg pirfenidone was administered on Day 1 and a single dose of 100 mg nintedanib was administered on Day 2. A washout period of at least 72 hours separated the last drug administration in the reference period from the first drug administration in the test period.

Drug: BI 1015550; Drug: Nintedanib; Drug: Pirfenidone

Interventions

BI 1015550 DRUG

BI 1015550

Also known as: Nerandomilast, JASCAYD®

Reference treatment/Test treatment

Nintedanib DRUG

Soft capsules

Also known as: Ofev®

Reference treatment/Test treatment

Pirfenidone DRUG

Film-coated tablets

Also known as: Esbriet®

Reference treatment/Test treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 1015550; nintedanib; pirfenidone

Results Point of Contact

• Title: Boehringer Ingelheim
• Organization: Boehringer Ingelheim, Call Centre

clintriage.rdg@boehringer-ingelheim.com

18002430127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: November 8, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)