Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Interventions
DRUGPLN-74809
PLN-74809
RADIATIONKnottin tracer
Radiotracer
Sponsors
Stanford University
Pliant Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
Open label, incomplete crossover, up to 2 single doses administered at two different times
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of IPF, within 5 years prior to Screening, * FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening. * DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening. * Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months
Exclusion criteria
* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA * Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \<0.7 * Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression * Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening * Smoking of any kind within 3 months of Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | Following 1 day of dosing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | From screening to 1 week following the administration of PLN-74809 | Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 60 mg PLN-74809: PLN-74809 (60 mg) | 1 |
| 120 mg and 240 mg PLN-74809: PLN-74809 (120 mg and 240 mg) | 1 |
| 320 mg PLN-74809: PLN-74809 (320 mg) | 1 |
| 240 mg and 320 mg PLN-74809: PLN-74809 (240 mg and 320 mg) | 2 |
| 320 mg and 120 mg PLN-74809: PLN-74809 (320 mg and120 mg) | 1 |
| 80 mg and 240 mg PLN-74809: PLN-74809 (80 mg and 240 mg) | 1 |
| 80 mg and 120 mg PLN-74809: PLN-74809 (80 mg and 120 mg) | 1 |
| 120 mg and 320 mg PLN-74809: PLN-74809 (120 mg and 320 mg) | 1 |
| Total | 9 |
Baseline characteristics
| Characteristic | Total | 320 mg | 120 mg and 240 mg | 240 mg and 320 mg | 320 mg and 120 mg | 80 mg and 240 mg | 80 mg and 120 mg | 60 mg | 120 mg and 320 mg |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 77.6 Years STANDARD_DEVIATION 4.36 | 76 Years STANDARD_DEVIATION 0 | 69 Years STANDARD_DEVIATION 0 | 83.5 Years STANDARD_DEVIATION 0.71 | 77 Years STANDARD_DEVIATION 0 | 76 Years STANDARD_DEVIATION 0 | 77 Years STANDARD_DEVIATION 0 | 77 Years STANDARD_DEVIATION 0 | 79 Years STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 9 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 1 / 1 | 0 / 2 | 0 / 1 | 1 / 1 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
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.
Time frame: Following 1 day of dosing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 60 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 1 Participants |
| 120 mg and 240 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 1 Participants |
| 320 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 0 Participants |
| 240 mg and 320 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 2 Participants |
| 320 mg and 120 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 1 Participants |
| 80 mg and 240 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 1 Participants |
| 80 mg and 120 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 1 Participants |
| 120 mg and 320 mg | Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. | 1 Participants |
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).
Time frame: From screening to 1 week following the administration of PLN-74809
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 60 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 0 Participants |
| 120 mg and 240 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 0 Participants |
| 320 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 1 Participants |
| 240 mg and 320 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 0 Participants |
| 320 mg and 120 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 0 Participants |
| 80 mg and 240 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 1 Participants |
| 80 mg and 120 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 0 Participants |
| 120 mg and 320 mg | Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events | 0 Participants |