Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Purpose
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Condition
- Idiopathic Pulmonary Fibrosis
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Open label, incomplete crossover, up to 2 single doses administered at two different times
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- No masking
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PLN-74809 Dose Level 1 (60 mg) |
PLN-74809 Dose Level 1 (60mg) |
|
|
Experimental PLN-74809 Dose Level 2 (80 mg) |
PLN-74809 Dose Level 2 (80 mg) |
|
|
Experimental PLN-74809 Dose Level 3 (120 mg) |
PLN-74809 Dose Level 3 (120 mg) |
|
|
Experimental PLN-74809 Dose Level 4 (240 mg) |
PLN-74809 Dose Level 4 (240 mg) |
|
|
Experimental PLN-74809 Dose Level 4 (320 mg) |
PLN-74809 Dose Level 4 (320 mg) |
|
Recruiting Locations
More Details
- NCT ID
- NCT04072315
- Status
- Completed
- Sponsor
- Pliant Therapeutics, Inc.