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Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ORIN1001
Placebo
Sponsored by
Orinove, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 40-80 years of age (inclusive) when signing the Informed Consent.
  2. Diagnosis of IPF or likely IPF per 2018 American Thoracic Society and European Respiratory Society (ATS/ERS) criteria:

    • Study Investigator will confirm IPF diagnosis based on Interstitial Lung Disease (ILD) in consultation with relevant experts through a review of the subject's history, high-resolution computerized tomography (HRCT) scan, and lung biopsy (if applicable).
    • A lung biopsy is not required in the setting of a compatible clinical history and usual interstitial pneumonia (UIP) or probable UIP per HRCT.
    • Study Investigators will verify that a diagnosis of IPF and an HRCT were obtained within 7 years prior to signing the ICF.
  3. Continued SOC IPF therapy (consisting of pirfenidone [Esbriet®] OR nintedanib [Ofev®] OR neither) is acceptable, provided stable dosing of the drug for at least 8 consecutive weeks immediately prior to signing the ICF.
  4. The effect of ORIN1001 on the developing human fetus, if any, is unknown. Therefore, for the duration of study participation:

    • Women who are postmenopausal for < 1 year before the Screening and not otherwise sterile (e.g., due to a surgical procedure) may be considered of child-bearing potential and require a negative pregnancy test prior to study registration. They must agree to (a) use effective contraception (i.e., hormonal or barrier method of birth control when engaged in heterosexual intercourse) or (b) abstinence throughout the study period AND for 4 weeks after final dosing with the IMP.
    • Men who are not otherwise sterile (e.g., due to a surgical procedure) must agree not to donate sperm and use effective contraception (i.e.,hormonal or barrier method of birth control when engaged in heterosexual intercourse) or abstinence throughout the study period AND for at least 16 weeks (due to the sperm life cycle) after final dosing with the IMP.
  5. Written informed consent must be given prior to any study-related procedure that is not part of standard medical care, understanding that the subject may withdraw it at any time without prejudice to future treatment.

Exclusion Criteria:

  1. Screening lab values that fail to meet the following criteria will render the subject ineligible for study participation:

    • Platelet count <100 × 109/L. Repeat measurements may be performed, but transfusion, in order to meet eligibility criteria, is not allowed.
    • Hemoglobin <12.9 g/dL (men) and <11.9 g/dL (women).
    • Prothrombin time (PT) or partial thromboplastin time (PTT) >1.5 × upper limit of normal; international normalized ratio (INR) >2.
    • Aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >1.5 × upper limit of normal (ULN).
    • Serum glutamic-oxaloacetic transaminase [SGOT] or serum glutamic pyruvic transaminase [SGPT]) >2.0 × ULN.
    • Kidney disease with estimated glomerular filtration rate <60 mL/min).
  2. Forced vital capacity (FVC) ≤40% of predicted normal per site pulmonary function lab protocol.
  3. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤30% of predicted normal as calculated according to the site pulmonary function lab protocol.
  4. Forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio < 0.7.
  5. Documented IPF exacerbation within 3 months of signing the ICF (e.g., >5% or 10% change in FVC and DLCO, respectively).
  6. Listing for lung transplantation, defined as the assignment of a lung allocation score or acceptance on the waiting list for lung transplantation.
  7. Current and/or uncontrolled cardiovascular condition (e.g., clinically significant arrhythmia or hypertension), >Class II heart failure per New York Heart Association criteria, unstable angina, myocardial infarction, coronary syndrome) within 6 months of Screening which, as judged by the Investigator, might put the subject at risk because of participation in the study.
  8. Known cirrhotic liver, chronic liver, or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones). Liver cirrhosis with portal hypertension and active liver infection are exclusionary (note: cured hepatitis C is not considered active).
  9. Gastrointestinal disease (e.g., active bleeding or ulcers) or procedure that could interfere with oral absorption or tolerance of the IMP, including difficulty swallowing.
  10. Diarrhea >Grade 1 (i.e., increase of >4 stools per day OR >1 watery stool per day OR moderate increase in ostomy output compared to baseline) will render a subject ineligible for participation in this study. Anti-diarrheal medication (e.g., loperamide, sold under the brand name Imodium®, among others) is allowed.
  11. Active malignancy within the past 12 months or ongoing active cancer treatment (surgery, radiotherapy, chemotherapy or immunotherapy), except for adequately treated Stage 1 cancer, nonmelanoma skin cancer, or in situ cervical cancer. Cancer in complete remission or requiring only maintenance therapy (e.g., tamoxifen for breast cancer) is not considered active.
  12. Known bleeding risk due to platelet dysfunction, or inherited or acquired clotting factor deficiency (e.g., von Willebrand disease, hemophilia).
  13. Major trauma or surgery including but not limited to operations involving a major organ (e.g., the cranium, chest, abdomen, or pelvic cavity) OR requiring a lengthy recovery period (e.g., arthroplasty) within 3 months of signing the ICF; or expected surgery during the trial period.
  14. Central nervous system hemorrhagic event within 12 months of signing ICF; brain arterio-venous malformation (AVM) or moderate-to-severe ischemic stroke within 6 months of signing ICF.
  15. Concurrent use of full-dose therapeutic anti-coagulation (e.g., vitamin K antagonist, dabigatran, hirudin, direct factor Xa inhibitors) or high dose anti-platelet therapy. Aspirin <81 mg/day, prophylactic subcutaneous (SC) heparin or SC low-molecular weight heparin for deep vein thrombosis prophylaxis or heparin flush to maintain intravenous catheter patency are allowed.
  16. Long-term use of nonsteroidal anti-inflammatory agents, defined as >4 days per week.
  17. Receipt of hematopoietic growth factors, blood or blood product transfusion within 1 week of the first dose of IMP.
  18. Disqualifying treatments within 60 days or 5 half-lives (whichever is longer) from Randomization include:

    • Systemic corticosteroids (>10 mg prednisone or equivalent).
    • Systemic immunosuppressive therapy.
    • Investigational agent other than study IMP.
  19. Recreational drug use (including amphetamines, cocaine, barbiturates, opiates, benzodiazepines, phencyclidine, and cannabinoids) for the duration of study participation.
  20. Clinically significant laboratory abnormality, medical or psychological comorbidity, or concurrent medication that could compromise subject safety, data integrity or requirements for study participation, per site Investigator in consultation with the Sponsor.
  21. Inability to attend in-person appointments per current clinical site COVID-19 guidelines and restrictions.

Sites / Locations

  • St. Francis Sleep, Allergy & Lung Institute
  • Mayo Clinic Hospital
  • Avanza Medical Research
  • Coastal Pulmonary and Critical Care
  • Loyola University Medical Center
  • University of Iowa Hospital
  • Infinity Medical Research
  • Hannibal Clinic
  • Dartmouth Hitchcock Medical Center
  • Duke University Hospital
  • University of Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

25 mg ORIN1001 (Active)

50 mg ORIN1001 (active)

100 mg ORIN1001 (active)

Placebo - 25 mg

Placebo - 50 mg

Placebo - 100 mg

Arm Description

25 mg ORIN1001

50 mg ORIN1001

100 mg ORIN1001

Placebo comparator for ORIN1001 at 25 mg

Placebo comparator for ORIN1001 at 50 mg

Placebo comparator for ORIN1001 at 100 mg

Outcomes

Primary Outcome Measures

Blood pressure
measurement of blood pressure
Heart Rate
measurement of heart rate
Respiratory Rate
Measurement of respiratory rate
Body Temperature
Measurement of body temperature
12-lead ECG
Cardiovascular evaluation to determine intervals including QTc interval
Serum Clinical Chemistry analysis
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
Whole blood Hematology analysis
WBC, RBC, Hb, HCT, MCV, MCH, MCHC, Neu, Lymphocytes, EOS, Bas, PLT
Whole blood Coagulation Parameters
PT, APTT, INR
Urinalysis
Bilrubin, glusoe, ketones, leukocytes, nitrite, blood, pH, specific gravity, protein, urobilinogen
Concomitant medications
Evaluation of other medications taken currently with investigative drug
Physical examination
Medical Health examination, medical history, medicine history, reproductive history, baseline information
Body weight
Body weight in kg
Spirometry
Pulmonary Function Tests: Forced vital capacity (FVC), Forced expiratory volume (FEV)
Height
Height in cm
Body mass index (BMI)
Calculation of BMI using weight (kg) and height (cm)
DLCO - Assessment of diffusion capacity
Lung test to assess diffusion capacity

Secondary Outcome Measures

Blood collection to measure drug concentration over time
Blood collection for evaluation of ORIN1001 exposure. Measurements will assess half life, exposure, maximum concentration, time to maximum concentration and accumulation ratios

Full Information

First Posted
November 11, 2020
Last Updated
July 16, 2023
Sponsor
Orinove, Inc.
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04643769
Brief Title
Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Official Title
Phase 1b Double-Blind, Placebo-Controlled, Ascending Dose Trial: ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orinove, Inc.
Collaborators
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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 (SOC) for IPF (i.e., pirfenidone or nintedanib). Approximately 24 evaluable subjects will be required for this study. Eligible subjects will be followed for safety through the dose-limiting toxicity (DLT) evaluation period, defined as 28 days after the first dose of ORIN1001. In the absence of intolerable toxicity, doses will be escalated sequentially with 8 evaluable subjects receiving a maximum of 28 days of ORIN1001 in once-daily doses of 25 mg (Cohort 1), 50 mg (Cohort 2), or 100 mg (Cohort 3) versus matched placebo. Subjects will be stratified based on local SOC for IPF, defined as the stable daily dose of pirfenidone or nintedanib (or neither) received for at least 8 weeks prior to signing the Informed Consent Form (ICF). ORIN1001 or matched placebo will be administered daily until Day 28, unacceptable toxicity, withdrawal for another reason or study termination. Safety Endpoints will be evaluated and will include adverse events (AEs), serious adverse events (SAEs), and changes in clinical laboratory evaluations as compared to baseline. Safety variables include but are not limited to: vital signs (blood pressure [BP], heart rate [HR], respiratory rate [RR]) and temperature; twelve-lead ECG; clinical laboratory tests (hematology, coagulation profile, clinical chemistry, and urinalysis); concomitant medications; physical examination; body weight; and pulmonary function tests (forced vital capacity [FVC], forced expiratory volume [FEV], and diffusion capacity [DLCO]) at baseline, End-of- Treatment and Follow-up Visits. Pharmacokinetic (PK) Endpoints will be evaluated on Day 1 and Day 28 and blood collection samples will be obtained from each subject. Exploratory serum biomarker endpoints will be evaluated to assess lung fibrosis and inflammation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Placebo-controlled, double blind
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
25 mg ORIN1001 (Active)
Arm Type
Experimental
Arm Description
25 mg ORIN1001
Arm Title
50 mg ORIN1001 (active)
Arm Type
Experimental
Arm Description
50 mg ORIN1001
Arm Title
100 mg ORIN1001 (active)
Arm Type
Experimental
Arm Description
100 mg ORIN1001
Arm Title
Placebo - 25 mg
Arm Type
Placebo Comparator
Arm Description
Placebo comparator for ORIN1001 at 25 mg
Arm Title
Placebo - 50 mg
Arm Type
Placebo Comparator
Arm Description
Placebo comparator for ORIN1001 at 50 mg
Arm Title
Placebo - 100 mg
Arm Type
Placebo Comparator
Arm Description
Placebo comparator for ORIN1001 at 100 mg
Intervention Type
Drug
Intervention Name(s)
ORIN1001
Intervention Description
Oral tablet - ORIN1001
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet - placebo
Primary Outcome Measure Information:
Title
Blood pressure
Description
measurement of blood pressure
Time Frame
Up to 60 days
Title
Heart Rate
Description
measurement of heart rate
Time Frame
Up to 60 days
Title
Respiratory Rate
Description
Measurement of respiratory rate
Time Frame
Up to 60 days
Title
Body Temperature
Description
Measurement of body temperature
Time Frame
Up to 60 days
Title
12-lead ECG
Description
Cardiovascular evaluation to determine intervals including QTc interval
Time Frame
Up to 60 days
Title
Serum Clinical Chemistry analysis
Description
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
Time Frame
Up to 60 days
Title
Whole blood Hematology analysis
Description
WBC, RBC, Hb, HCT, MCV, MCH, MCHC, Neu, Lymphocytes, EOS, Bas, PLT
Time Frame
Up to 60 dys
Title
Whole blood Coagulation Parameters
Description
PT, APTT, INR
Time Frame
Up to 60 days
Title
Urinalysis
Description
Bilrubin, glusoe, ketones, leukocytes, nitrite, blood, pH, specific gravity, protein, urobilinogen
Time Frame
Up to 60 days
Title
Concomitant medications
Description
Evaluation of other medications taken currently with investigative drug
Time Frame
Up to 60 days
Title
Physical examination
Description
Medical Health examination, medical history, medicine history, reproductive history, baseline information
Time Frame
Up to 60 days
Title
Body weight
Description
Body weight in kg
Time Frame
Up to 60 days
Title
Spirometry
Description
Pulmonary Function Tests: Forced vital capacity (FVC), Forced expiratory volume (FEV)
Time Frame
Up to 60 days
Title
Height
Description
Height in cm
Time Frame
Up to 60 days
Title
Body mass index (BMI)
Description
Calculation of BMI using weight (kg) and height (cm)
Time Frame
Up to 60 days
Title
DLCO - Assessment of diffusion capacity
Description
Lung test to assess diffusion capacity
Time Frame
Up to 60 days
Secondary Outcome Measure Information:
Title
Blood collection to measure drug concentration over time
Description
Blood collection for evaluation of ORIN1001 exposure. Measurements will assess half life, exposure, maximum concentration, time to maximum concentration and accumulation ratios
Time Frame
Up to 29 days
Other Pre-specified Outcome Measures:
Title
Exploratory biomarkers to evaluate lung fibrosis
Description
Blood collection for evaluation of disease biomarker of lung fibrosis: SP-D, MMP-7 and KL6. Specific biomarker to be determined
Time Frame
Up to 60 days
Title
Quality of Life Questionnaire
Description
Questionnaire to assess the quality of life during the study period
Time Frame
Up to 60 days
Title
Exploratory biomarkers to evaluate inflammation
Description
Blood collection for evaluation of inflammation such as cytokines TGF-B and/or IL-6
Time Frame
Up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40-80 years of age (inclusive) when signing the Informed Consent. Diagnosis of IPF or likely IPF per 2018 American Thoracic Society and European Respiratory Society (ATS/ERS) criteria: Study Investigator will confirm IPF diagnosis based on Interstitial Lung Disease (ILD) in consultation with relevant experts through a review of the subject's history, high-resolution computerized tomography (HRCT) scan, and lung biopsy (if applicable). A lung biopsy is not required in the setting of a compatible clinical history and usual interstitial pneumonia (UIP) or probable UIP per HRCT. Study Investigators will verify that a diagnosis of IPF and an HRCT were obtained within 7 years prior to signing the ICF. Continued SOC IPF therapy (consisting of pirfenidone [Esbriet®] OR nintedanib [Ofev®] OR neither) is acceptable, provided stable dosing of the drug for at least 8 consecutive weeks immediately prior to signing the ICF. The effect of ORIN1001 on the developing human fetus, if any, is unknown. Therefore, for the duration of study participation: Women who are postmenopausal for < 1 year before the Screening and not otherwise sterile (e.g., due to a surgical procedure) may be considered of child-bearing potential and require a negative pregnancy test prior to study registration. They must agree to (a) use effective contraception (i.e., hormonal or barrier method of birth control when engaged in heterosexual intercourse) or (b) abstinence throughout the study period AND for 4 weeks after final dosing with the IMP. Men who are not otherwise sterile (e.g., due to a surgical procedure) must agree not to donate sperm and use effective contraception (i.e.,hormonal or barrier method of birth control when engaged in heterosexual intercourse) or abstinence throughout the study period AND for at least 16 weeks (due to the sperm life cycle) after final dosing with the IMP. Written informed consent must be given prior to any study-related procedure that is not part of standard medical care, understanding that the subject may withdraw it at any time without prejudice to future treatment. Exclusion Criteria: Screening lab values that fail to meet the following criteria will render the subject ineligible for study participation: Platelet count <100 × 109/L. Repeat measurements may be performed, but transfusion, in order to meet eligibility criteria, is not allowed. Hemoglobin <12.9 g/dL (men) and <11.9 g/dL (women). Prothrombin time (PT) or partial thromboplastin time (PTT) >1.5 × upper limit of normal; international normalized ratio (INR) >2. Aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >1.5 × upper limit of normal (ULN). Serum glutamic-oxaloacetic transaminase [SGOT] or serum glutamic pyruvic transaminase [SGPT]) >2.0 × ULN. Kidney disease with estimated glomerular filtration rate <60 mL/min). Forced vital capacity (FVC) ≤40% of predicted normal per site pulmonary function lab protocol. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤30% of predicted normal as calculated according to the site pulmonary function lab protocol. Forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio < 0.7. Documented IPF exacerbation within 3 months of signing the ICF (e.g., >5% or 10% change in FVC and DLCO, respectively). Listing for lung transplantation, defined as the assignment of a lung allocation score or acceptance on the waiting list for lung transplantation. Current and/or uncontrolled cardiovascular condition (e.g., clinically significant arrhythmia or hypertension), >Class II heart failure per New York Heart Association criteria, unstable angina, myocardial infarction, coronary syndrome) within 6 months of Screening which, as judged by the Investigator, might put the subject at risk because of participation in the study. Known cirrhotic liver, chronic liver, or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones). Liver cirrhosis with portal hypertension and active liver infection are exclusionary (note: cured hepatitis C is not considered active). Gastrointestinal disease (e.g., active bleeding or ulcers) or procedure that could interfere with oral absorption or tolerance of the IMP, including difficulty swallowing. Diarrhea >Grade 1 (i.e., increase of >4 stools per day OR >1 watery stool per day OR moderate increase in ostomy output compared to baseline) will render a subject ineligible for participation in this study. Anti-diarrheal medication (e.g., loperamide, sold under the brand name Imodium®, among others) is allowed. Active malignancy within the past 12 months or ongoing active cancer treatment (surgery, radiotherapy, chemotherapy or immunotherapy), except for adequately treated Stage 1 cancer, nonmelanoma skin cancer, or in situ cervical cancer. Cancer in complete remission or requiring only maintenance therapy (e.g., tamoxifen for breast cancer) is not considered active. Known bleeding risk due to platelet dysfunction, or inherited or acquired clotting factor deficiency (e.g., von Willebrand disease, hemophilia). Major trauma or surgery including but not limited to operations involving a major organ (e.g., the cranium, chest, abdomen, or pelvic cavity) OR requiring a lengthy recovery period (e.g., arthroplasty) within 3 months of signing the ICF; or expected surgery during the trial period. Central nervous system hemorrhagic event within 12 months of signing ICF; brain arterio-venous malformation (AVM) or moderate-to-severe ischemic stroke within 6 months of signing ICF. Concurrent use of full-dose therapeutic anti-coagulation (e.g., vitamin K antagonist, dabigatran, hirudin, direct factor Xa inhibitors) or high dose anti-platelet therapy. Aspirin <81 mg/day, prophylactic subcutaneous (SC) heparin or SC low-molecular weight heparin for deep vein thrombosis prophylaxis or heparin flush to maintain intravenous catheter patency are allowed. Long-term use of nonsteroidal anti-inflammatory agents, defined as >4 days per week. Receipt of hematopoietic growth factors, blood or blood product transfusion within 1 week of the first dose of IMP. Disqualifying treatments within 60 days or 5 half-lives (whichever is longer) from Randomization include: Systemic corticosteroids (>10 mg prednisone or equivalent). Systemic immunosuppressive therapy. Investigational agent other than study IMP. Recreational drug use (including amphetamines, cocaine, barbiturates, opiates, benzodiazepines, phencyclidine, and cannabinoids) for the duration of study participation. Clinically significant laboratory abnormality, medical or psychological comorbidity, or concurrent medication that could compromise subject safety, data integrity or requirements for study participation, per site Investigator in consultation with the Sponsor. Inability to attend in-person appointments per current clinical site COVID-19 guidelines and restrictions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Averill, MD
Organizational Affiliation
Sleep, Allergy and Lung Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Francis Sleep, Allergy & Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Mayo Clinic Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Avanza Medical Research
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Coastal Pulmonary and Critical Care
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33704
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Iowa Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Infinity Medical Research
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Hannibal Clinic
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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