Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT03727802
Last Updated: 2023-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2018-11-28
2022-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRK-250
TRK-250
single and multiple doses (4 weeks)
Placebo
Placebo
single and multiple doses (4 weeks)
Interventions
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TRK-250
single and multiple doses (4 weeks)
Placebo
single and multiple doses (4 weeks)
Eligibility Criteria
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Inclusion Criteria
* SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.
* FVC ≥50% of predicted.
* FEV1 ≥50% of predicted.
* Ratio of FEV1 to FVC ≥0.7.
* DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.
Exclusion Criteria
* Planned surgery during the study.
* History of malignant tumor within 5 years prior to Screening.
* History of emphysema or clinically significant respiratory diseases (other than IPF).
* Other known causes of interstitial lung disease (eg, drug toxicities, environmental exposures, connective tissue diseases).
* End-stage fibrotic disease expected to require organ transplantation within 6 months.
* Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening. (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted, provided that the subject has been on a stable dose for at least 4 weeks prior to Screening and it is anticipated the dose will remain unchanged throughout enrollment.)
40 Years
80 Years
ALL
No
Sponsors
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Toray Industries, Inc
INDUSTRY
Responsible Party
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Locations
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Pulmonary Associates
Phoenix, Arizona, United States
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL
Kissimmee, Florida, United States
Weill Cornell Medicine
New York, New York, United States
PulmonIx LLC
Greensboro, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program
Charleston, South Carolina, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Doi H, Atsumi J, Baratz D, Miyamoto Y. A Phase I Study of TRK-250, a Novel siRNA-Based Oligonucleotide, in Patients with Idiopathic Pulmonary Fibrosis. J Aerosol Med Pulm Drug Deliv. 2023 Dec;36(6):300-308. doi: 10.1089/jamp.2023.0014. Epub 2023 Sep 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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250IPF01
Identifier Type: -
Identifier Source: org_study_id
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