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| Name | Class |
|---|---|
| Stanford University | OTHER |
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A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLN-74809 Dose Level 1 (60 mg) | Experimental | PLN-74809 Dose Level 1 (60mg) |
|
| PLN-74809 Dose Level 2 (80 mg) | Experimental | PLN-74809 Dose Level 2 (80 mg) |
|
| PLN-74809 Dose Level 3 (120 mg) | Experimental | PLN-74809 Dose Level 3 (120 mg) |
|
| PLN-74809 Dose Level 4 (240 mg) | Experimental | PLN-74809 Dose Level 4 (240 mg) |
|
| PLN-74809 Dose Level 4 (320 mg) | Experimental | PLN-74809 Dose Level 4 (320 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLN-74809 | Drug | PLN-74809 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling. | Following 1 day of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14). | From screening to 1 week following the administration of PLN-74809 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pliant Therapeutics Medical Monitor | Pliant Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Medical Center | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499805 | Derived | Mooney JJ, Jacobs S, Lefebvre EA, Cosgrove GP, Clark A, Turner SM, Decaris M, Barnes CN, Jurek M, Williams B, Duan H, Kimura R, Rizzo G, Searle G, Wardak M, Guo HH. Bexotegrast Shows Dose-Dependent Integrin alphavbeta6 Receptor Occupancy in Lungs of Participants with Idiopathic Pulmonary Fibrosis: A Phase 2, Open-Label Clinical Trial. Ann Am Thorac Soc. 2025 Mar;22(3):350-358. doi: 10.1513/AnnalsATS.202409-969OC. |
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The first participant on this study was enrolled in February 2020 and the last participant in May 2022. The enrollment period was prolonged due to the limited clinical trial operations at the research site, caused by COVID-19 pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 60 mg | PLN-74809: PLN-74809 (60 mg) Knottin tracer: Radiotracer |
| FG001 | 120 mg and 240 mg | PLN-74809: PLN-74809 (120 mg and 240 mg) Knottin tracer: Radiotracer |
| FG002 | 320 mg | PLN-74809: PLN-74809 (320 mg) Knottin tracer: Radiotracer |
| FG003 | 240 mg and 320 mg | PLN-74809: PLN-74809 (240 mg and 320 mg) Knottin tracer: Radiotracer |
| FG004 | 320 mg and 120 mg | PLN-74809: PLN-74809 (320 mg and 120 mg) Knottin tracer: Radiotracer |
| FG005 | 80 mg and 240 mg | PLN-74809: PLN-74809 (80 mg and 240 mg) |
| FG006 | 80 mg and 120 mg | PLN-74809: PLN-74809 (80 mg and 120 mg) |
| FG007 | 120 mg and 320 mg | PLN-74809: PLN-74809 (120 mg and 320 mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 60 mg | PLN-74809: PLN-74809 (60 mg) |
| BG001 | 120 mg and 240 mg | PLN-74809: PLN-74809 (120 mg and 240 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling. | Posted | Count of Participants | Participants | Following 1 day of dosing |
|
15 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 60 mg | PLN-74809 (60 mg) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gamma-glutamyltransferase increased | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment | Elevated Gamma Glutamyl Transferase |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Éric Lefebvre, M.D., Chief Medical Officer | Pliant Therapeutics, Inc. | 1-650-481-6779 | ELefebvre@pliantrx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2021 | Jul 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2022 | Jul 13, 2023 | SAP_001.pdf |
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| 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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Open label, incomplete crossover, up to 2 single doses administered at two different times
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No masking
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| Knottin tracer | Radiation | Radiotracer |
|
| BG002 |
| 320 mg |
PLN-74809: PLN-74809 (320 mg) |
| BG003 | 240 mg and 320 mg | PLN-74809: PLN-74809 (240 mg and 320 mg) |
| BG004 | 320 mg and 120 mg | PLN-74809: PLN-74809 (320 mg and120 mg) |
| BG005 | 80 mg and 240 mg | PLN-74809: PLN-74809 (80 mg and 240 mg) |
| BG006 | 80 mg and 120 mg | PLN-74809: PLN-74809 (80 mg and 120 mg) |
| BG007 | 120 mg and 320 mg | PLN-74809: PLN-74809 (120 mg and 320 mg) |
| BG008 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| 320 mg |
PLN-74809: PLN-74809 (320 mg) Knottin tracer: Radiotracer |
| OG003 | 240 mg and 320 mg | PLN-74809: PLN-74809 (240 mg and 320 mg) Knottin tracer: Radiotracer |
| OG004 | 320 mg and 120 mg | PLN-74809: PLN-74809 (320 mg and 120 mg) Knottin tracer: Radiotracer |
| OG005 | 80 mg and 240 mg | PLN-74809: PLN-74809 (80 mg and 240 mg) Knottin tracer: Radiotracer |
| OG006 | 80 mg and 120 mg | PLN-74809: PLN-74809 (80 mg and 120 mg) Knottin tracer: Radiotracer |
| OG007 | 120 mg and 320 mg | PLN-74809: PLN-74809 (120 mg and 320 mg) Knottin tracer: Radiotracer |
|
|
| Secondary | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14). | Posted | Count of Participants | Participants | From screening to 1 week following the administration of PLN-74809 |
|
|
|
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 120 mg and 240 mg | PLN-74809 (120 mg and 240 mg) | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | 320 mg | PLN-74809 (320 mg) | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | 240 mg and 320 mg | PLN-74809 (240 mg and 320 mg) | 0 | 2 | 0 | 2 | 0 | 2 |
| EG004 | 320 mg and 120 mg | PLN-74809 (320 mg and 120 mg) | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | 80 mg and 240 mg | PLN-74809 (80 mg and 240 mg) | 0 | 1 | 0 | 1 | 1 | 1 |
| EG006 | 80 mg and 120 mg | PLN-74809 (80 mg and 120 mg) | 0 | 1 | 0 | 1 | 0 | 1 |
| EG007 | 120 mg and 320 mg | PLN-74809 (120 mg and 320 mg) | 0 | 1 | 0 | 1 | 0 | 1 |
|
| Hepatic Enzyme Increased | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment | Elevated liver enzymes (AST, ALT, AlkP'tase) |
|
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