A study in healthy men to test whether BI 1015550 influences the amount of nintedanib and pirfenidone in the blood

Start 8 Nov 2023 · End 14 Dec 2023 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol 1305-0034

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 14

Countries 1

Sites 1

Healthy volunteer trial

The main objective of this trial is to investigate the induction effect of multiple oral doses of of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.

Key facts

Sponsor: Boehringer Ingelheim International GmbH
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male
Therapeutic area: Not possible to specify
Trial duration: 8 Nov 2023 → 14 Dec 2023
Decision date (initial): 2023-09-22
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2023-505522-34-00
WHO UTN: U1111-1292-0376

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

The main objective of this trial is to investigate the induction effect of multiple oral doses of of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.

Conditions and MedDRA coding

Healthy volunteer trial

Version	Level	Code	Term	System organ class
21.0	LLT	10053349	Pharmacokinetic study	10022891

Study design 4 periods

#	Title	Allocation	Blinding	Arms
1	Screening period up to 13 days (from day -14 to Day -2)	Not Applicable	None	All participants: All participants
2	Reference Treatment period 5 days	Not Applicable	None	All participants: During the Reference Treatment ( R ) period the participants will be given pirfenidone on Day 1 of the R period and nintedanib on Day 2 of R period.
3	Test Treatment period 10 days	Not Applicable	None	All participants: During the Test Treatment ( T ) period the participants will be given BI 1015550 for 10 days together with pirfenidone on Day 1 of T period and nintedanib on Day 2 of T period.
4	Follow-up period up to 15 days	Not Applicable	None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Age of 18 to 55 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion criteria 5

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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

for nintedanib: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
for nintedanib: Cmax (maximum measured concentration of the analyte in plasma)
for nintedanib: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
for pirfenidone: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
for pirfenidone: Cmax (maximum measured concentration of the analyte in plasma)
for pirfenidone: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

BI 1015550

PRD10442862 · Product

Active substance: BI 1015550
Pharmaceutical form: FILM COATED TABLET
Route of administration: ORAL USE
Max daily dose: 36 mg milligram(s)
Max total dose: 360 mg milligram(s)
Max treatment duration: 10 Day(s)
Authorisation status: Not Authorised
MA holder: BOEHRINGER INGELHEIM INTERNATIONAL
Paediatric formulation: No
Orphan designation: No

Ofev 100 mg soft capsules

PRD2386450 · Product

Active substance: Nintedanib
Substance synonyms: BIBF 1120
Pharmaceutical form: CAPSULE, SOFT
Route of administration: ORAL USE
Max daily dose: 100 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 2 Day(s)
Authorisation status: Authorised
ATC code: L01XE31 — -
Marketing authorisation: EU/1/14/979/002
MA holder: BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Esbriet 267 mg film-coated tablets

PRD5847540 · Product

Active substance: Pirfenidone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 267 mg milligram(s)
Max total dose: 534 mg milligram(s)
Max treatment duration: 2 Day(s)
Authorisation status: Authorised
ATC code: L04AX05 — -
Marketing authorisation: EU/1/11/667/017
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation: Boehringer Ingelheim International GmbH
Address: Binger Strasse 173
City: Ingelheim Am Rhein
Postcode: 55216
Country: Germany

Scientific contact point

Organisation: Boehringer Ingelheim International GmbH
Contact name: CT Disclosure & Data Transparency

Public contact point

Organisation: Boehringer Ingelheim International GmbH
Contact name: CT Disclosure & Data Transparency

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ended	14	1
Rest of world	—	0	—

Investigational sites

Germany

1 site · Ended

Boehringer Ingelheim Pharma GmbH & Co. KG

Humanpharmakologisches Zentrum Biberach -Global Clinical Development & Operations, Birkendorfer Strasse 65, 88397, Biberach An Der Riss

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2023-11-08	2023-12-14	2023-11-09	2023-11-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
1305-0034 CTR synopsis SUM-55669	2024-11-06T08:35:01	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
1305-0034 Lay Summary	2024-11-06T08:35:08	Submitted	Laypersons Summary of Results

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Laypersons summary of results (for publication)	1305-0034-lay-summary-english	1
Laypersons summary of results (for publication)	1305-0034-lay-summary-german	1
Summary of results (for publication)	1305-0034-ctr-synopsis-NOT-public	1
Summary of results (for publication)	1305-0034-ctr-synopsis-public	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-06-27	Germany	Acceptable 2023-08-25	2023-09-22