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This Study Tests Different Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF). The Study Tests How BI 1015550 is Taken up by the Body and How Well it is Tolerated.

Study Purpose

The primary objective is to investigate safety and tolerability of BI 1015550 in patients with IPF. The secondary objectives are to investigate the effect of BI 1015550 on the target engagement biomarker and to evaluate the pharmacokinetics (PK) of BI 1015550 in patients with IPF.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Signed and dated written informed consent prior to admission to the study in accordance with ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation - Male or female patients aged ≥40 years at visit 1.
  • - A clinical diagnosis of IPF based on ATS/ERS/JRS/ALAT 2011 guideline within the previous 5 years as confirmed by the investigator based on chest high-resolution computed tomography (HRCT) scan taken within 12 months of visit 1 and confirmed by central review prior to visit 2.
  • - Forced Vital Capacity (FVC) ≥50% of predicted normal at visit 1 - Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb] [Visit 1]): > 30% of predicted normal at visit 1

    Exclusion Criteria:

    - Patients with a significant disease or condition other than IPF which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patient's ability to participate in the study.
  • - Any laboratory value outside the reference range that the investigator considers to be of clinical relevance - Surgery of the GI tract that could interfere with PK of the trial medication (except appendectomy) - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders including but not limited to mood disorders.
  • - Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.
  • - History of allergy or hypersensitivity to the trial medication or its excipients - Use of drugs within 30 days prior to administration of trial medication that are known to influence the results of the trial including time between start of the Q-wave and the end of the T-wave in an electrocardiogram (QT) / QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB) (QTc) - A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening - A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome) - Participation in another trial where an investigational drug has been administered within 30 days or less than 5 half-lives (whichever is greater) of the respective drug prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug.
  • - Inability to refrain from smoking on trial days - Alcohol abuse (consumption of more than 20 g per day) - Active drug abuse - Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial - Inability to comply with dietary regimen required for the trial - Patient is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study - Male patients who do not agree to minimize the risk of female partners becoming pregnant from first dosing day until two months after the study completion.
Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive used for at least two months prior), true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient), or surgically sterilized, including vasectomy.
  • - Females who are not surgically sterilised or who are not postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory).
  • - Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at visit 1 - Patients who have previously been treated with nintedanib or pirfenidone within 30 days of visit 1.
  • - Positive fecal occult blood (no retest allowed), - Positive testing for hematuria if confirmed by microscopic urine analysis (retest allowed) - Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) - Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought without method, intent or plan; active suicidal thought with method, but without intent or plan; active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent and plan).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03422068
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Brussels - UNIV Saint-Luc, Bruxelles, Belgium

Status

Recruiting

Address

Brussels - UNIV Saint-Luc

Bruxelles, , 1200

Site Contact

Antoine Froidure

antoine.froidure@uclouvain.be

+32 02 7642832

Odense University Hospital, Odense, Denmark

Status

Recruiting

Address

Odense University Hospital

Odense, , 5000 C

Site Contact

Ingrid Titlestad

ingrid.titlestad@rsyd.dk

4565412740

HYKS Keuhkosairauksien, Helsinki, Finland

Status

Recruiting

Address

HYKS Keuhkosairauksien

Helsinki, , 00290

Site Contact

Marjukka Myllärniemi

marjukka.myllarniemi@hus.fi

35894711

TYKS, Keuhkosairauksien klinikka, Turku, Turku, Finland

Status

Recruiting

Address

TYKS, Keuhkosairauksien klinikka, Turku

Turku, , 20520

Site Contact

Maritta Kilpeläinen

maritta.kilpelainen@tyks.fi

35823134739

HOP Côte de Nacre, Caen, France

Status

Recruiting

Address

HOP Côte de Nacre

Caen, , 14033

Site Contact

Emmanuel Bergot

bergot-e@chu-caen.fr

+33 (0)2 31 06 46 76

HOP Pontchaillou, Rennes, France

Status

Recruiting

Address

HOP Pontchaillou

Rennes, , 35033

Site Contact

Stéphane Jouneau

stephane.jouneau@chu-rennes.fr

+33 (0)2 99 28 24 78

Essen, Germany

Status

Recruiting

Address

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, , 45239

Großhansdorf, Germany

Status

Recruiting

Address

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, , 22927

Site Contact

Anne-Marie Kirsten

a.kirsten@pulmoresearch.de

+49 (4102) 8881109

Fraunhofer ITEM, Hannover, Germany

Status

Recruiting

Address

Fraunhofer ITEM

Hannover, , 30625

Universitätsklinikum Heidelberg, Heidelberg, Germany

Status

Recruiting

Address

Universitätsklinikum Heidelberg

Heidelberg, , 69126

Site Contact

Michael Kreuter

kreuter@uni-heidelberg.de

+49 (6221) 3961201

Policlinico Gemelli, Roma, Italy

Status

Recruiting

Address

Policlinico Gemelli

Roma, , 00168

Nieuwegein, Netherlands

Status

Recruiting

Address

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, , 3435 CM

Erasmus Medisch Centrum, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus Medisch Centrum

Rotterdam, , 3015 CE

Site Contact

Marlies Wijsenbeek

m.wijsenbeek-lourens@erasmusmc.nl

+31(0)10-7040704

Hospital Clínic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clínic de Barcelona

Barcelona, , 08036

Site Contact

Jacobo Sellares

SELLARES@clinic.cat

+34932275400

Hospital de Bellvitge, L'Hospitalet de Llobregat, Spain

Status

Recruiting

Address

Hospital de Bellvitge

L'Hospitalet de Llobregat, , 08907

Site Contact

María Molina-Molina

mariamolinamolina@hotmail.com

+34932607089

Hospital Son Espases, Palma de Mallorca, Spain

Status

Recruiting

Address

Hospital Son Espases

Palma de Mallorca, , 07120

Site Contact

Jaume Sauleda

jaume.sauleda@ssib.es

+34871206718

Royal Brompton Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Brompton Hospital

London, , SW3 6NP

Site Contact

Philip Molyneaux

p.molyneaux@rbht.nhs.uk

+44 207 352 8121

Southampton General Hospital, Southampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital

Southampton, , SO16 6YD

Site Contact

Sophie Fletcher

sophie.fletcher@uhs.nhs.uk

02381 206663