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Trial record 3 of 106 for:    Recruiting, Not yet recruiting, Available Studies | (idiopathic pulmonary fibrosis)

Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03727802
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Toray Industries, Inc

Brief Summary:
TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level. This study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: TRK-250 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: TRK-250 Drug: TRK-250
single and multiple doses (4 weeks)

Placebo Comparator: Placebo Drug: Placebo
single and multiple doses (4 weeks)




Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Up to 7 days after last dose ]

Secondary Outcome Measures :
  1. AUC from time zero to the time of the last quantifiable concentration (AUC0-t last) [ Time Frame: Up to 60 minutes after dose ]
  2. Cmax [ Time Frame: Up to 60 minutes after dose ]
  3. Tmax [ Time Frame: Up to 60 minutes after dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical, radiographic, and histologic features consistent with the diagnosis of IPF
  • 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:

  • History of acute exacerbation of IPF or respiratory tract infection within 3 months prior to Screening.
  • 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.)

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): NCT03727802


Contacts
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Contact: TRK-250 team +81-3-3245-8576 Clinicaltrials-info@nts.toray.co.jp

Locations
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United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
United States, California
Cedars-Sinai Medical Center (CSMC) - Women's Guild Lung Institute Recruiting
Los Angeles, California, United States, 90048
United States, Florida
Advanced Pulmonary & Sleep Research Institute of Florida Recruiting
Daytona Beach, Florida, United States, 32117
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Pulmonary Disease Specialists, PA, d/b/a PDS Research. Kissimmee, FL Recruiting
Kissimmee, Florida, United States, 34741
University of Miami Leonard M. Miller School of Medicine (UMMSM) - Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
United States, North Carolina
PulmonIx LLC Recruiting
Greensboro, North Carolina, United States, 27403
United States, South Carolina
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Toray Industries, Inc

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Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT03727802     History of Changes
Other Study ID Numbers: 250IPF01
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toray Industries, Inc:
TRK-250
Idiopathic Pulmonary Fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial