Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: PLN-74809
Product Code: PLN-74809
Pharmaceutical Form: Oral solution
INN or Proposed INN: Not Available
Current Sponsor code: PLN-74809
Other descriptive name: PLN-74809-000
Concentrat
Sponsors
Pliant Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants, aged 40 years or older. 2. Diagnosis of IPF for up to 5 years prior to screening based on ATS/ERS/JRS/ALAT 2018 guidelines (Raghu et al, 2018) Note: If IPF diagnosis is within >3 to =5 years at screening, the participant must have evidence of progression within the last 24 months, as defined by decline in FVC percent predicted based on a relative decline of = 5% 3. FVC percent of predicted =45%; historical FVC for entry in the study is permitted if within 1 month of screening 4. Diffusing capacity for carbon monoxide (DLco) (hemoglobin-adjusted) =30%%; historical DLco for entry in the study is permitted if within 1 month of screening 5. Participants currently receiving treatment for IPF with nintedanib or pirfenidone are allowed, provided these drugs have been given at a stable dose for at least 3 months before the Screening Visit and are expected to remain unchanged during the study stable dose is defined as the highest dose tolerated by the participant during = 3 months) 6. Estimated glomerular filtration rate = 50 mL/min, according to the Cockcroft-Gault equation 7. Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for at least 2 years 8. Female participants of childbearing potential (i.e., ovulating, pre-menopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential must use highly effective methods of birth control during their participation in the study and for 90 days after the last administration of study drug. Hormonal contraceptives are not allowed. Highly effective methods of birth control are defined as those with 99% or greater efficacy. 9. Participants must agree to abstain from sperm or egg donation through 90 days after administration of the last dose of study drug 10. Able to read and sign a written informed consent form (ICF) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Receiving any non-approved agent intended for treatment of fibrosis in IPF 2. Forced expiratory volume during the first second (FEV1) over the forced vital capacity (FVC) ratio (FEV1/FVC ratio) 450 msec for males or >460 msec for females at the Screening visit (including Day -1) or prior to administration of the initial dose of study drug. 14. Any of the following liver function test criteria above specified limits: total bilirubin >1.5× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN; alkaline phosphatase >2.5× ULN. Note: participants currently receiving nintedanib or pirfenidone as IPF SoC treatment, who have previously presented any liver function test elevations associated with nintedanib or pirfenidone treatment greater than that described above or resulting in dose reduction, treatment interruption, or discontinuation are not eligible. 15. Any of the following at Screening: hemoglobin <10.0 g/dL, or neutrophils <1500 /mm3, or platelets <100.000 /mL 16. Pregnant or lactating females 17. Daily use of phosphodiesterase-5 (PDE-5) inhibitor drugs (e.g., sildenafil, tadalafil, other) (Note: Intermittent use for erectile dysfunction is allowed.) 18. A medical or surgical condition known to affect drug absorption (e.g., major gastric surgery) 19. Surgical procedures planned to occur during the study period 20. Uncontrolled systemic arterial hypertension 21. Has participated in a clinical trial with an investigational agent in the 30 days prior to Screening 22. Likely to have lung transplantation during the study (being on transplantation list is acceptable) 23. Any medical condition that, in the opinion of the Investigator, may make candidates not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the safety and tolerability of PLN-74809 following daily administration for up to 12 weeks;Secondary Objective: Assessment of pharmacokinetics (PK) of PLN-74809;Primary end point(s): Primary Safety Endpoint Nature and proportion of AEs between PLN-74809 and placebo groups (descriptive) Safety data from all participants who received at least one dose of study drug will be incorporated into the final safety analysis. Further details of the safety analyses will be provided in the SAP. AEs will be collected from the time the participant signs the ICF until the last study visit. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug.;Timepoint(s) of evaluation of this end point: Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. Secondary Pharmacokinetic Endpoints Plasma PLN-74809 concentrations (total and unbound concentrations) at each sampling time point will be presented in listings and descriptive summary statistics by dose and visit. The data will also be presented graphically. Further details of the analyses will be provided in the SAP to be prepared and agreed prior to final ‘database lock’ at the end of the study. The PK analysis plan and report may be prepared separately from the SAP as appropriate. b. Secondary Pharmacodynamic Endpoints Urine, plasma and serum samples will be analyzed for biomarkers (presence or actual concentration). These samples will be used to determine the levels of these markers in participants and the relationship between these markers. Results will be presented by listings, descriptive summary statistics and in graphical form by treatment and dose and expressed as the relative change (and or absolute) for each participant. In addition, relationships between PK and PD may be evaluated in an exploratory fashion and presented in graphical manner.;Timepoint(s) of evaluation of this end point: Week 10 | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Netherlands, New Zealand, United Kingdom, United States
Contacts
Public ContactMonica Sandberg
Pliant Therapeutics Inc.
Outcome results
None listed