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Oral ORIN1001 for Idiopathic Pulmonary Fibrosis
Phase 1
Waitlist Available
Led By Frank Averill, MD
Research Sponsored by Orinove, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 dys
Summary
This trial is testing a new drug, ORIN1001, to see if it is safe and effective in treating adults with idiopathic pulmonary fibrosis (IPF). The trial will have 3 groups of 8 people, who will either receive the new drug or a placebo. The trial will last 28 days.
Who is the study for?
Adults aged 40-80 with confirmed idiopathic pulmonary fibrosis (IPF) can join this trial. They must have been on a stable dose of standard IPF care for at least 8 weeks and agree to use effective contraception. Excluded are those with severe lung function impairment, certain blood disorders, liver disease, recent major surgery or trauma, active cancer within the past year, or any condition that could affect safety or data integrity.
What is being tested?
The trial is testing ORIN1001 in three different doses (25 mg, 50 mg, or 100 mg) taken daily for up to 28 days against a placebo. It's double-blind and includes subjects who will be randomly assigned to either the drug or placebo group while continuing their usual IPF treatments.
What are the potential side effects?
While specific side effects of ORIN1001 aren't listed here, common concerns in trials like these include gastrointestinal issues due to oral medication intake and potential interactions with existing medications or conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 dys
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 dys
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
12-lead ECG
Blood pressure
Body Temperature
+13 moreSecondary study objectives
Blood collection to measure drug concentration over time
Other study objectives
Exploratory biomarkers to evaluate inflammation
Exploratory biomarkers to evaluate lung fibrosis
Quality of Life Questionnaire
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: 50 mg ORIN1001 (active)Experimental Treatment1 Intervention
50 mg ORIN1001
Group II: 25 mg ORIN1001 (Active)Experimental Treatment1 Intervention
25 mg ORIN1001
Group III: 100 mg ORIN1001 (active)Experimental Treatment1 Intervention
100 mg ORIN1001
Group IV: Placebo - 25 mgPlacebo Group1 Intervention
Placebo comparator for ORIN1001 at 25 mg
Group V: Placebo - 50 mgPlacebo Group1 Intervention
Placebo comparator for ORIN1001 at 50 mg
Group VI: Placebo - 100 mgPlacebo Group1 Intervention
Placebo comparator for ORIN1001 at 100 mg
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,355 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
8,000 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Orinove, Inc.Lead Sponsor
2 Previous Clinical Trials
500 Total Patients Enrolled
Frank Averill, MDPrincipal InvestigatorSleep, Allergy and Lung Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lungs are not able to absorb carbon monoxide well, as determined by a lung function test.Your lung function is less than 40% of what is expected for someone your age and size.Your lung function test shows that you have trouble breathing out air.You have a stomach or intestine condition that might make it hard for your body to absorb or handle the study drug.You have a liver disease like cirrhosis or long-term liver or bile duct problems.Your SGOT or SGPT levels are more than double the normal range.Your lab test results do not meet the required standards.You are currently taking strong blood thinners or high-dose blood clot prevention medications.You have a known risk of bleeding because of problems with your blood platelets or clotting factors.You have been diagnosed with or likely have a lung condition called idiopathic pulmonary fibrosis (IPF) based on specific medical criteria from 2018.Your hemoglobin levels are lower than 12.9 g/dL if you are a man, or lower than 11.9 g/dL if you are a woman.Your blood clotting tests show that your blood takes longer than normal to clot.You have kidney disease with a low filtration rate.You have had a worsening of your IPF within the last 3 months before joining the study.You don't need to have a lung biopsy if your medical history and high-resolution CT scan suggest a specific type of lung disease.Your liver enzymes AST or ALT are more than 1.5 times the normal level.You have been taking nonsteroidal anti-inflammatory drugs for a long time.You have a heart condition that is not under control.You have had cancer or are currently being treated for cancer in the past year.You had bleeding in your brain within the last year before joining the study.Your platelet count is less than 100 billion per liter.You have diarrhea that is more than mild.
Research Study Groups:
This trial has the following groups:- Group 1: 25 mg ORIN1001 (Active)
- Group 2: 50 mg ORIN1001 (active)
- Group 3: 100 mg ORIN1001 (active)
- Group 4: Placebo - 25 mg
- Group 5: Placebo - 50 mg
- Group 6: Placebo - 100 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04643769 — Phase 1
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