GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis (GKT137831)

STATUS

Recruiting
days left to enroll

61
participants needed

60
sponsor

University of Alabama at Birmingham

Updated on 2 May 2022

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pulmonary disease

idiopathic pulmonary fibrosis

forced vital capacity

Summary

A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. Treatment with GKT137831 could result in significant benefit for a lung disease that has, until now, been almost invariably inexorable.

This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal.

Details

Condition	Idiopathic Pulmonary Fibrosis
Treatment	Placebo Oral Tablet, GKT137831
Clinical Study Identifier	NCT03865927
Sponsor	University of Alabama at Birmingham
Last Modified on	2 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age between 40-85 years old
	A diagnosis of IPF that fulfills current American Thoracic Society (ATS) Consensus Criteria
	IPF duration <5 years, based on the date of definitive diagnosis
	Ability and willingness to give informed consent and adhere to study requirements
	Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) >70% of predicted values
Exclusion Criteria
	Diagnosis of major comorbidities expected to interfere with study participation
	History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen <10 ng/dl. NOX inhibition is not known to promote cancer, and these criteria are within current guidelines
	The occurrence of any acute infection requiring systemic antibiotic therapy within 2 weeks prior to Screening (Visit 1)
	Treatment for >14 days within the preceding month with >20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), given increased risks of opportunistic infections
	Treatment with any investigational agent within 4 weeks of Screening (Visit 1) or 5 half-lives of the investigational medicinal product (whichever is longer)
	Fertile women who do not agree to contraception or abstinence, or who are breast feeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration
	Subjects with known hypersensitivity to GKT137831 or its excipients (e.g. capsule "bulking" agents)
	A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin < 10.0 g/dL (or 6.2 mmol/L)
	Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, congestive heart failure (NYHA Class III or IV), or stroke, including a transient ischemic attack
	Evidence of cardiac conducting abnormalities, defined as second or third degree atrial-ventricular (AV) block not successfully treated with a pacemaker, or a personal or family history of long QT syndrome (QTc interval >450 msec for males or 470 msec for females)
	End-stage renal disease requiring dialysis
	Undergoing transplantation evaluation, or listed with the United Network for Organ Sharing (UNOS) as a lung transplantation candidate at the time of enrollment in this trial
	Liver function tests (transaminases, alkaline phosphatase, direct and total bilirubin) >3x upper limit of normal values

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GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis (GKT137831)