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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06070610

U1111-1292-0376 (Registry Identifier)

2023-505522-34-00 (Registry Identifier)

1305-0034

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Reference treatment/Test treatment

Experimental group

Description:

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.

Treatment:

Drug: Pirfenidone

Drug: Nintedanib

Drug: BI 1015550