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.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03422068
• Date of registration: 22/01/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: 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.
• Scientific 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 Therapy.
• Date of first enrolment: March 16, 2018
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03422068
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom

Key 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).



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: BI 1015550

Drug: Placebo

Primary Outcome(s)

Safety and tolerability of BI 1015550 by the percentage of patients with drug-related AEs on-treatment [Time Frame: Up to 35 days]

Secondary Outcome(s)

AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) [Time Frame: Day 14]

Cmax (maximum measured concentration of the analyte in plasma) [Time Frame: Day 1]

Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over [Time Frame: Day 14]

AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) [Time Frame: Day 1]

Secondary ID(s)

2017-002736-16

1305-0012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors