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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)	Drug: PLN-74809 PLN-74809 Radiation: Knottin tracer Radiotracer
Experimental PLN-74809 Dose Level 2 (80 mg)	PLN-74809 Dose Level 2 (80 mg)	Drug: PLN-74809 PLN-74809 Radiation: Knottin tracer Radiotracer
Experimental PLN-74809 Dose Level 3 (120 mg)	PLN-74809 Dose Level 3 (120 mg)	Drug: PLN-74809 PLN-74809 Radiation: Knottin tracer Radiotracer
Experimental PLN-74809 Dose Level 4 (240 mg)	PLN-74809 Dose Level 4 (240 mg)	Drug: PLN-74809 PLN-74809 Radiation: Knottin tracer Radiotracer
Experimental PLN-74809 Dose Level 4 (320 mg)	PLN-74809 Dose Level 4 (320 mg)	Drug: PLN-74809 PLN-74809 Radiation: Knottin tracer Radiotracer

Recruiting Locations

More Details

NCT ID: NCT04072315
Status: Completed
Sponsor: Pliant Therapeutics, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.