Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
This Phase 1b trial is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of oral ORIN1001 at 25 mg, 50 mg or 100 mg administered daily for up to 28 days in adult subjects with idiopathic pulmonary fibrosis (IPF) alone or in conjunction with local Standard of Care for IPF (pirfenidone or nintedanib). A maximum of 24 evaluable subjects will be required to complete the study. The study will consist of 3 dose cohorts each enrolling a maximum of 8 subjects randomized either to the active (5 subjects) group or placebo (3 subjects) group. Each subject will receive daily oral doses of ORIN1001 or placebo for 28 days. The safety and pharmacokinetic profile will be evaluated in this study and will include cardiovascular and pulmonary endpoints.
Description: measurement of blood pressure
Measure: Blood pressure Time: Up to 60 daysDescription: measurement of heart rate
Measure: Heart Rate Time: Up to 60 daysDescription: Measurement of respiratory rate
Measure: Respiratory Rate Time: Up to 60 daysDescription: Measurement of body temperature
Measure: Body Temperature Time: Up to 60 daysDescription: Cardiovascular evaluation to determine intervals including QTc interval
Measure: 12-lead ECG Time: Up to 60 daysDescription: ALT, albumin, ALP, AST, BUN, Ca, Cl, Cholesterol, Creatinine, CK, CA, Elastase, GGT, glucose, HDL, LDH, lipase, LDL, phosphorus, sodium, Total bilirubin, Total protein, Triglycerides, Uric acid, Lipid panel
Measure: Serum Clinical Chemistry analysis Time: Up to 60 daysDescription: WBC, RBC, Hb, HCT, MCV, MCH, MCHC, Neu, Lymphocytes, EOS, Bas, PLT
Measure: Whole blood Hematology analysis Time: Up to 60 dysDescription: PT, APTT, INR
Measure: Whole blood Coagulation Parameters Time: Up to 60 daysDescription: Bilrubin, glusoe, ketones, leukocytes, nitrite, blood, pH, specific gravity, protein, urobilinogen
Measure: Urinalysis Time: Up to 60 daysDescription: Evaluation of other medications taken currently with investigative drug
Measure: Concomitant medications Time: Up to 60 daysDescription: Medical Health examination, medical history, medicine history, reproductive history, baseline information
Measure: Physical examination Time: Up to 60 daysDescription: Body weight in kg
Measure: Body weight Time: Up to 60 daysDescription: Pulmonary Function Tests: Forced vital capacity (FVC), Forced expiratory volume (FEV)
Measure: Spirometry Time: Up to 60 daysDescription: Height in cm
Measure: Height Time: Up to 60 daysDescription: Calculation of BMI using weight (kg) and height (cm)
Measure: Body mass index (BMI) Time: Up to 60 daysDescription: Lung test to assess diffusion capacity
Measure: DLCO - Assessment of diffusion capacity Time: Up to 60 daysDescription: Blood collection for evaluation of ORIN1001 exposure. Measurements will assess half life, exposure, maximum concentration, time to maximum concentration and accumulation ratios
Measure: Blood collection to measure drug concentration over time Time: Up to 29 daysDescription: Blood collection for evaluation of disease biomarker of lung fibrosis: SP-D, MMP-7 and KL6. Specific biomarker to be determined
Measure: Exploratory biomarkers to evaluate lung fibrosis Time: Up to 60 daysDescription: Questionnaire to assess the quality of life during the study period
Measure: Quality of Life Questionnaire Time: Up to 60 daysDescription: Blood collection for evaluation of inflammation such as cytokines TGF-B and/or IL-6
Measure: Exploratory biomarkers to evaluate inflammation Time: Up to 60 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports