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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Toray Industries, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: TRK-250
Drug: Placebo
Enrollment 34
Recruitment Details A total of 34 subjects were randomized to treatment, with 16 subjects in Part A and 18 subjects in Part B.
Pre-assignment Details  
Arm/Group Title PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo
Hide Arm/Group Description single dose of TRK-250 single dose of TRK-250 single dose of TRK-250 single dose of TRK-250 single dose of Placebo multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of Placebo
Period Title: Overall Study
Started 3 3 3 3 4 4 4 4 6
Completed 3 3 3 3 4 4 4 3 5
Not Completed 0 0 0 0 0 0 0 1 1
Arm/Group Title PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo Total
Hide Arm/Group Description single dose of TRK-250 single dose of TRK-250 single dose of TRK-250 single dose of TRK-250 single dose of Placebo multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of Placebo Total of all reporting groups
Overall Number of Baseline Participants 3 3 3 3 4 4 4 4 6 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 3 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants 4 participants 6 participants 34 participants
74
(70 to 76)
70
(66 to 73)
76
(70 to 80)
69
(66 to 74)
75
(67 to 79)
64
(48 to 74)
70
(59 to 75)
74
(66 to 78)
75
(70 to 77)
72
(48 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants 4 participants 6 participants 34 participants
Female
2
  66.7%
1
  33.3%
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
7
  20.6%
Male
1
  33.3%
2
  66.7%
2
  66.7%
2
  66.7%
4
 100.0%
4
 100.0%
4
 100.0%
2
  50.0%
6
 100.0%
27
  79.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 3 participants 3 participants 3 participants 3 participants 4 participants 4 participants 4 participants 4 participants 6 participants 34 participants
White
3
 100.0%
3
 100.0%
2
  66.7%
3
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
6
 100.0%
33
  97.1%
Black or African Black or African American
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
1.Primary Outcome
Title Incidence and Severity of Adverse Events
Hide Description Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Time Frame Up to 14 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo
Hide Arm/Group Description:
single dose of TRK-250
single dose of TRK-250
single dose of TRK-250
single dose of TRK-250
single dose of Placebo
multiple doses (4 weeks) of TRK-250
multiple doses (4 weeks) of TRK-250
multiple doses (4 weeks) of TRK-250
multiple doses (4 weeks) of Placebo
Overall Number of Participants Analyzed 3 3 3 3 4 4 4 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with AEs
1
  33.3%
0
   0.0%
3
 100.0%
2
  66.7%
1
  25.0%
3
  75.0%
2
  50.0%
3
  75.0%
3
  50.0%
Mild(Severity)
0
   0.0%
0
   0.0%
2
  66.7%
1
  33.3%
1
  25.0%
2
  50.0%
1
  25.0%
0
   0.0%
3
  50.0%
Moderate(Severity)
1
  33.3%
0
   0.0%
1
  33.3%
1
  33.3%
0
   0.0%
1
  25.0%
1
  25.0%
2
  50.0%
0
   0.0%
Severe(Severity)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Time Frame Up to 14 days after last dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo
Hide Arm/Group Description single dose of TRK-250 single dose of TRK-250 single dose of TRK-250 single dose of TRK-250 single dose of Placebo multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of TRK-250 multiple doses (4 weeks) of Placebo
All-Cause Mortality
PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   0/4 (0.00%)   1/4 (25.00%)   0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Acute respiratory failure † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PartA:TRK-250 2mg PartA:TRK-250 10mg PartA:TRK-250 30mg PartA:TRK-250 60mg PartA:Pooled Placebo PartB:TRK-250 10mg PartB:TRK-250 30mg PartB:TRK-250 60mg PartB:Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   0/3 (0.00%)   3/3 (100.00%)   2/3 (66.67%)   1/4 (25.00%)   3/4 (75.00%)   2/4 (50.00%)   3/4 (75.00%)   3/6 (50.00%) 
Cardiac disorders                   
Arrhythmia † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Bundle branch block right † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Eye disorders                   
Glaucoma † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Anal fissure † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Constipation † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Diarrhoea † 1  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Nausea † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Infections and infestations                   
Urinary tract infection † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Investigations                   
Alanine aminotransferase increased † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Aspartate aminotransferase increased † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Eosinophil count increased † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Heart rate irregular † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                   
Hyponatraemia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Bursitis † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Myalgia † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders                   
Urinary retention † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Acute respiratory failure † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Cough † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Dyspnoea † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Dyspnoea exertional † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Laryngospasm † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Nasal congestion † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Productive cough † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Pulmonary congestion † 1  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Rales † 1  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
1
Term from vocabulary, MedDRA 21.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Information Desk
Organization: Toray Industries, Inc
Phone: +81-3-3245-8576
EMail: clinical-trials.toray.mb@mail.toray
Layout table for additonal information
Responsible Party: Toray Industries, Inc
ClinicalTrials.gov Identifier: NCT03727802    
Other Study ID Numbers: 250IPF01
First Submitted: October 24, 2018
First Posted: November 1, 2018
Results First Submitted: December 21, 2022
Results First Posted: October 23, 2023
Last Update Posted: October 23, 2023