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

• ClinicalTrials.gov Identifier: NCT03727802
• Recruitment Status: Completed
• First Posted: November 1, 2018
• Results First Posted: October 23, 2023
• Last Update Posted: October 23, 2023
• Sponsor: Toray Industries, Inc
• Information provided by (Responsible Party): Toray Industries, Inc

Tracking Information

• First Submitted Date: October 24, 2018
• First Posted Date: November 1, 2018
• Results First Submitted Date: December 21, 2022
• Results First Posted Date: October 23, 2023
• Last Update Posted Date: October 23, 2023
• Actual Study Start Date: November 28, 2018
• Actual Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 21, 2022)

Incidence and Severity of Adverse Events [ Time Frame: Up to 14 days after last dose ]

Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events

• Original Primary Outcome Measures (submitted: October 31, 2018): Incidence and severity of adverse events [ Time Frame: Up to 7 days after last dose ]
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: October 31, 2018)

• AUC from time zero to the time of the last quantifiable concentration (AUC0-t last) [ Time Frame: Up to 60 minutes after dose ]
• Cmax [ Time Frame: Up to 60 minutes after dose ]
• Tmax [ Time Frame: Up to 60 minutes after dose ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: TRK-250
  single and multiple doses (4 weeks)
• Drug: Placebo
  single and multiple doses (4 weeks)

Study Arms

• Experimental: TRK-250
  Intervention: Drug: TRK-250
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 31, 2018): 34
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 1, 2022
• Actual Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03727802
• Other Study ID Numbers: 250IPF01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Toray Industries, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Toray Industries, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Toray Industries, Inc
• Verification Date: June 2022