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The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTI-101 400 mg/day | Experimental | Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks. |
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| TTI-101 800 mg/day | Experimental | Participants will receive 800 mg/day of TTI-101 BID for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive a matching placebo BID for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTI-101 | Drug | Orally via a tablet. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with an Adverse Event (AE) | Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of TTI-101 | Day 1 to Week 12 | |
| Time of Maximum Observed Plasma Concentration (tmax) of TTI-101 | Day 1 to Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic of University of Alabama Birmingham Hospital | Birmingham | Alabama | 35233 | United States | ||
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| Placebo |
| Drug |
Orally via a tablet. |
|
| Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101 |
| Day 1 to Week 12 |
| Trough Plasma Concentration (Cτ) of TTI-101 | Day 1 to Week 12 |
| University of California San Diego |
| La Jolla |
| California |
| 92037 |
| United States |
| University of California Irvine (UCI) Health | Orange | California | 92868 | United States |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
| Saint Francis Sleep Allergy and Lung Institute | Clearwater | Florida | 33765 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| UHealth - University of Miami Health Systems | Miami | Florida | 33125 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112-2600 | United States |
| The Lung Research Center | Chesterfield | Missouri | 63017 | United States |
| New York University Langone Pulmonary and Critical Care Associates | Brooklyn | New York | 10017 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Pulmonix | Greensboro | North Carolina | 27403 | United States |
| Salem Chest Specialists | Winston-Salem | North Carolina | 27103-4007 | United States |
| Saint Luke's University Hospital - Bethlehem | Bethlehem | Pennsylvania | 18020 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| The Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Clinical Trials Center of Middle Tennessee | Franklin | Tennessee | 37067 | United States |
| Baylor Scott & White Center for Advanced Heart & Lung Disease | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston (UT Health) | Houston | Texas | 77030 | United States |
| Metroplex Pulmonary and Sleep Center | McKinney | Texas | 75069 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000625861 | C188-9 compound |
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