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A Dose Ranging Study Evaluating Efficacy and Safety of NI-03

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ClinicalTrials.gov Identifier: NCT02693093
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Stason Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to determine the safety and efficacy of NI-03.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: NI-03 Drug: Placebo Phase 1 Phase 2

Detailed Description:

The primary objective of the Single-Dose Phase is to assess the pharmacokinetics (PK) and safety of single doses of NI-03 when administered at doses of 100 mg, 200 mg or 300 mg to subjects with chronic pancreatitis.

The primary objective of the Double-Blind Phase of the study is to determine the efficacy, PK and safety of three doses of NI-03 (100 mg, 200 mg and 300 mg) as compared to placebo when administered three times daily (TID) for 28 consecutive days in subjects with chronic pancreatitis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis
Study Start Date : December 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Placebo Comparator: placebo
TID Day for 28 Days
Drug: Placebo
Experimental: 100 mg NI-03
TID Day for 28 Days
Drug: NI-03
Experimental: 200 mg NI-03
TID Day for 28 Days
Drug: NI-03
Experimental: 300 mg NI-03
TID Day for 28 Days
Drug: NI-03



Primary Outcome Measures :
  1. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose ]
    Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), apparent clearance (CL/F), and apparent volume of distribution (Vz/F) are assessed.

  2. Phase 1 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0 [ Time Frame: through 7 days post-dose ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3. Phase 1 - Safety and Tolerability - Laboratory test results [ Time Frame: through 7 days post-dose ]
    Laboratory test results will be graded and summarized based on CTCAE v4.03. and by shifts in results before and after dosing

  4. Phase 2 - Efficacy Analysis - average daily worst pain intensity score [ Time Frame: 4 Weeks ]

Secondary Outcome Measures :
  1. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  2. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - Maximum concentration (Cmax) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  3. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - time to maximum plasma concentration (tmax) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  4. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent clearance (CL/F) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  5. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - plasma terminal half-life (t1/2) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  6. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent volume of distribution (Vz/F) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  7. Phase 2 - Efficacy Analysis - Change from baseline in least pain score [ Time Frame: change from baseline to Week 4 ]
  8. Phase 2 - Efficacy Analysis - Change from baseline in average pain score [ Time Frame: 4 Weeks ]
  9. Phase 2 - Efficacy Analysis - Change from baseline in current pain score [ Time Frame: 4 Weeks ]
  10. Phase 2 - Efficacy Analysis - Change from baseline in average morphine-equivalent daily opioid daily dose [ Time Frame: 4 Weeks ]
  11. Phase 2 - Efficacy Analysis - Change from baseline in quality of life [ Time Frame: change from baseline to Week 4 ]
    assessed using the pain interference aspects of the Brief Pain Inventory (BPI)

  12. Phase 2 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0 [ Time Frame: Through day 57 (End of Study Visit) ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  13. Phase 2 - Safety and tolerability - Laboratory Test Results [ Time Frame: Through day 57 (End of Study Visit) ]
    Laboratory test results will be graded and summarized based on CTCAE v4.03. and by shifts in results before and after dosing

  14. Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC) [ Time Frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose ]
  15. Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - Maximum concentration (Cmax) [ Time Frame: pre-dose and at 0.25, 0.5, 1, 2, 4 and 8 hours post-dose. ]
  16. Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - time to maximum plasma concentration (tmax) [ Time Frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose ]
  17. Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - plasma terminal half-life (t1/2) [ Time Frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose ]
  18. Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent clearance (CL/F) [ Time Frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose ]
  19. Phase 2 - To determine the pharmacokinetic profile for FOY251 and GBA - apparent volume of distribution (Vz/F) [ Time Frame: Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate in this study, subjects must meet all of the following criteria at Screening:

  1. Males and females aged 18 to 85 years, inclusive, at the time of consent
  2. Ability to communicate effectively with clinic site staff, ability and willingness to comply with the study schedule, restrictions, and requirements
  3. Institutional Review Board (IRB)-approved written informed
  4. Diagnosis of chronic pancreatitis
  5. Baseline average daily worst pain score must be a minimum of 4 using the Numeric Rating Scale (NRS) during the 7-day run-in period
  6. Patients on a non-opioid analgesic regimen that is expected to remain stable during the study period, or an opioid regimen with a morphine-equivalent dose not more than 100 mg daily.

Exclusion Criteria:

To be eligible to participate in this study, subjects must not meet any of the following criteria:

  1. Any other clinically significant medical condition
  2. Treatment with any investigational product within 14 days of Day 1 (or 5 drug half-lives if 5 drug half-lives are expected to exceed 14 days) of Day -7
  3. Major abdominal surgery within 90 days of Day 1
  4. History or presence of clinically significant cardiovascular disease
  5. History of any cancer, except non-melanoma skin cancer, within 5 years of study enrollment,
  6. History of endoscopic intervention within the previous 3 months or presence of a pancreatic duct stent
  7. History of illicit drug abuse (i.e. use of any 'illegal' drugs within 6 months)
  8. Active heavy alcohol use (defined as more than 2 alcoholic drinks per day or 14 alcoholic drinks per week)
  9. Inadequate venous access
  10. Significant blood loss, donation of ≥450 mL of blood, or blood or blood product transfusion within 7 days of Day 1
  11. History or presence of hepatitis B (surface antigen positivity), active hepatitis C or human immunodeficiency virus (HIV) antibody
  12. Active infection within 30 days of Day 1
  13. Pregnant, planning to become pregnant or breast feeding
  14. Positive urine or serum pregnancy test result at Screening or on Day 1
  15. Active major psychiatric illness requiring a change in treatment within 3 months that would confound pain assessments
  16. History of seizures within the last 12 months
  17. Current use of anticonvulsants, antipsychotics, systemic steroids and, immunosuppressant therapy. *Use of gabapentin, pregabalin and benzodiazepines as treatment for chronic pancreatitis pain are allowed.
  18. Presence of generalized pain syndrome apart from chronic pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693093


Contacts
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Contact: Aidan Nuttall, PhD 760 672 2640 aidan.nuttall@kangenpharma.co.jp
Contact: Melissa Summers 404-271-4419 melissa.summers@synteract.com

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Locations
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United States, Arizona
Mayo Clinic - Scottsdale Withdrawn
Scottsdale, Arizona, United States, 85259
United States, Arkansas
University of Arkansas Recruiting
Little Rock, Arkansas, United States, 72204
Contact: Diana Gregory    501-526-6990    dgregory@uams.edu   
United States, California
Kaiser Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact: Olivia Bravo    323-738-1542    olivia.bravo@kp.org   
University of Southern California, Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Jessica Serna    323-409-6939    sernaj@usc.edu   
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Liliana Bancila    310-423-3872    liliana.bancila@cshs.org   
Stanford University School of Medicine* Recruiting
Stanford, California, United States, 94305
Contact: Judith Chang    650-724-1336    judithcc@stanford.edu   
United States, Colorado
University of Colorado-Div of Gastroenterology and Hepatology Recruiting
Aurora, Colorado, United States, 80045
Contact: Eze Ezekwe    303-724-1862    eze.ezekwe@ucdenver.edu   
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Mahin Dawood    203-785-5505    mahin.dawood@yale.edu   
United States, Florida
University of Florida - Division of Gastroenterology Recruiting
Gainesville, Florida, United States, 32608
Contact: Tiffany Harrison    352-265-8982    Tiffany.Harrison@medicine.ufl.edu   
The Center for Gastrointestinal Disorders Withdrawn
Hollywood, Florida, United States, 33021
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
Contact: Nancy Chaffin    904-680-0871    nchaffin01@bgclinic.com   
Meridien Research Withdrawn
Lakeland, Florida, United States, 33805
Gastroenterology Group of Naples Recruiting
Naples, Florida, United States, 34102
Contact: Rose Furgal    239-649-1336    rfurgalresearch@embarqmail.com   
United States, Georgia
Gastrointestinal Specialists of Georgia, PC Withdrawn
Marietta, Georgia, United States, 30060
United States, Illinois
The Carle Foundation Hospital Recruiting
Urbana, Illinois, United States, 61801
Contact: Christine Canfield    217-326-0080    christine.canfield@carle.com   
United States, Indiana
Indiana University - Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202-5149
Contact: Gail McNulty    317-948-3684    gmcnulty@iu.edu   
United States, Kentucky
University of Louisville - Health Care Outpatient Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Mechelle Stoner    502-852-7407    mechelle.stoner@louisville.edu   
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Mahya Faghih    443-761-9157    Mfaghih2@jhu.edu   
United States, Massachusetts
Beth Israel Deaconess Medical Center Withdrawn
Boston, Massachusetts, United States, 02215
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Karen Gallagher-Dorval    508-856-2857    Karen.gallagher-dorval@umassmed.edu   
United States, Michigan
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
Contact: Joe Palmer    586-598-3329    jpalmer@researchmi.com   
Gastroenterology Associates of Western Michigan Recruiting
Wyoming, Michigan, United States, 49519
Contact: Bridgett Klooster    616-608-8738    bklooster@gastro-assoc-wm.com   
Contact: Ashley Ginder    616-328-5319    jaginder@gastro-assoc-wm.com   
United States, Minnesota
Mayo Clinic Withdrawn
Rochester, Minnesota, United States, 55902
United States, Missouri
Kansas City Research Institute Recruiting
Kansas City, Missouri, United States, 64131
Contact: Kelly Vargas    816-759-5274    kvargas@kcresearchinstitute.com   
United States, Nebraska
University of Nebraska Medical Center Withdrawn
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Anna Haron    603-653-3667    Anna.M.Haron@hitchcock.org   
United States, New York
Winthrop University Hospital Withdrawn
Mineola, New York, United States, 11501
Columbia University School of Medicine Recruiting
New York, New York, United States, 10027
Contact: Emil Agarunov    212-342-3781    ea2715@CUMC.Columbia.edu   
United States, North Carolina
Duke University Health System Withdrawn
Durham, North Carolina, United States, 27710
PMG Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Sydney Navy    336-768-8062    Sydney.navy@pmg-research.com   
United States, Ohio
Ohio Gl & Liver Institute/Consultants for Clinical Research Withdrawn
Cincinnati, Ohio, United States, 45219
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Kristine Russ    216-778-5278    kruss@metrohealth.org   
Ohio State University (OSU) - Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Brianna Conley    614-366-4495    brianna.conley@osumc.edu   
United States, Pennsylvania
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2536
Contact: Kelley Wood    412-648-7442    etheringtonka@upmc.edu   
United States, South Carolina
Medical University of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Nathan Wilson    843-792-8272    wilsonn@musc.edu   
United States, Texas
Texas Clinical Research Institute Recruiting
Arlington, Texas, United States, 76012
Contact: Ian Mumm    817-471-1070    imum@tcri.us   
Digestive Health Associates of Texas Withdrawn
Dallas, Texas, United States, 75208
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Chandra Kovvali    732-543-5322    chandralekha.kovvali@BCM.edu   
United States, Utah
Val R. Hansen, MD Withdrawn
Bountiful, Utah, United States, 84010
United States, Washington
Virginia Mason Recruiting
Seattle, Washington, United States, 98101
Contact: Cheryl Shaw    206-341-1786    Cheryl.shaw@virginiamason.org   
United States, Wisconsin
Wisconsin Center for Advanced Research, a division of GI Associates LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Kelly Dunneboil    414-908-6630    kellyd@wigia.com   
Sponsors and Collaborators
Stason Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stason Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02693093     History of Changes
Other Study ID Numbers: NI03-001
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases