Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/

Trial ID or NCT#

NCT04072315

Status

not recruiting iconNOT RECRUITING

Purpose

A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.

Official Title

A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF

Eligibility Criteria

Ages Eligible for Study: Older than 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Joshua Mooney
Joshua Mooney
Pulmonologist, Interstitial lung disease specialist, Lung transplant specialist, Heart and lung transplant specialist
Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine

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Contact

Joshua Mooney, MD