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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 June 2022
• Main ID: NCT03727802
• Date of registration: 24/10/2018
• Prospective Registration: Yes
• Primary sponsor: Toray Industries, Inc
• Public title: Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
• Scientific 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
• Date of first enrolment: November 28, 2018
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03727802
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.)



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: TRK-250

Drug: Placebo

Primary Outcome(s)

Incidence and severity of adverse events [Time Frame: Up to 7 days after last dose]

Secondary Outcome(s)

Tmax [Time Frame: Up to 60 minutes after dose]

Cmax [Time Frame: Up to 60 minutes after dose]

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

Secondary ID(s)

250IPF01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors