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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. The Study Also Looks at BI 1015550 When it is Taken in Addition to Nintedanib and Pirfenidone

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ClinicalTrials.gov Identifier: NCT03422068
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

Part 1: Multiple Rising Dose (MRD) 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

Part 2: On top of standard of care (SOC) The primary objective is to evaluate the safety and tolerability of the identified dose of BI 1015550 from Part 1 in patients with IPF on top of nintedanib and pirfenidone, respectively.

The secondary objectives are to evaluate the pharmacokinetics of BI 1015550 when co-administered with nintedanib and pirfenidone.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: BI 1015550 Drug: Placebo Drug: Background Therapy Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 in Patients With Idiopathic Pulmonary Fibrosis (IPF) on no Background Anti-fibrotic (Part 1) and Safety and Tolerability of BI 1015550 on Top of Nintedanib and Pirfenidone (Part 2)
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : December 3, 2018
Estimated Study Completion Date : December 10, 2018


Arm Intervention/treatment
Experimental: BI 1015550 Drug: BI 1015550
Tablet formulation

Drug: Background Therapy
Nintedanib and Pirfenidone

Placebo Comparator: Placebo Drug: Placebo
Tablet formulation

Drug: Background Therapy
Nintedanib and Pirfenidone




Primary Outcome Measures :
  1. Safety and tolerability of BI 1015550 by the number (%) of patients with drug-related AEs [ Time Frame: Up to 12 weeks (part 1) Up to 4 weeks (part 2) ]

Secondary Outcome Measures :
  1. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose) [ Time Frame: Day 1 ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: Day 1 ]
  3. AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [ Time Frame: Day 14 ]
  4. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over [ Time Frame: Day 14 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Current treatment with nintedanib 150mg b.i.d or pirfenidone 801 mg t.i.d for at least 12 weeks prior to Visit 1 (Part 2).

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
  • For part 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 fecal calprotectin (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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422068


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Finland
HYKS Keuhkosairauksien Recruiting
Helsinki, Finland, 00290
Contact: Marjukka Myllärniemi    35894711    marjukka.myllarniemi@hus.fi   
TYKS, Keuhkosairauksien klinikka, Turku Recruiting
Turku, Finland, 20520
Contact: Maritta Kilpeläinen    35823134739    maritta.kilpelainen@tyks.fi   
Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein Recruiting
Nieuwegein, Netherlands, 3435 CM
Contact: M. Veltkamp    +31(0)88-3203000    m.veltkamp@antoniusziekenhuis.nl   
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Marlies Wijsenbeek    +31(0)10-7040704    m.wijsenbeek-lourens@erasmusmc.nl   
Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Jacobo Sellares    +34932275400    SELLARES@clinic.cat   
Hospital de Bellvitge Recruiting
L'Hospitalet de Llobregat, Spain, 08907
Contact: María Molina-Molina    +34932607089    mariamolina@bellvitgehospital.cat   
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
Contact: Philip Molyneaux    +44 207 352 8121    p.molyneaux@rbht.nhs.uk   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03422068     History of Changes
Other Study ID Numbers: 1305-0012
2017-002736-16 ( EudraCT Number )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Nintedanib
Pirfenidone
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents