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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02693093
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Kangen 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)
Actual Enrollment : 264 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
Actual Study Start Date : February 24, 2016
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : December 30, 2021

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 consent
  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


Locations
Hide Hide 48 study locations
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United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72204
United States, California
Kaiser Permanente Medical Group
Los Angeles, California, United States, 90027
University of Southern California, Keck School of Medicine
Los Angeles, California, United States, 90033
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
University of Colorado-Div of Gastroenterology and Hepatology
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
University of Florida - Division of Gastroenterology
Gainesville, Florida, United States, 32608
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
United States, Illinois
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University - Indiana University Hospital
Indianapolis, Indiana, United States, 46202-5149
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, United States, 49519
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Columbia University School of Medicine
New York, New York, United States, 10027
United States, North Carolina
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio State University (OSU) - Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213-2536
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Virginia Mason
Seattle, Washington, United States, 98101
United States, Wisconsin
Wisconsin Center for Advanced Research, a division of GI Associates LLC
Milwaukee, Wisconsin, United States, 53215
Russian Federation
Federal Research Centre Institute of Cytology and Genetics
Novosibirsk, Russian Federation, 630089
Military Medical Academu, Dep of Therapy of Adv. Training
Saint Petersburg, Russian Federation, 191015
Military Medical Academy, Department of Hospital Therapy
Saint Petersburg, Russian Federation, 191124
1st Saint Petersburg State Medical University
Saint Petersburg, Russian Federation, 197022
City Hospital #40
Saint Petersburg, Russian Federation, 197706
City Polyclinic #4
Saint Petersburg, Russian Federation, 199178
Medical University "Reaviz"
Samara, Russian Federation, 443011
Tomsk Regional Clinical Hospital
Tomsk, Russian Federation, 634063
Ukraine
Institute of Gastroenterology
Dnipro, Ukraine, 49074
Central city Clinical Hospital, Therapeutic Department #2
Ivano-Frankivsk, Ukraine, 76018
Malaya Therapy National Institute
Kharkiv, Ukraine, 61039
City Policlinic #9
Kharkiv, Ukraine, 61172
City Hospital Named After Tropins, Therapy Department #1
Kherson, Ukraine, 73000
OK Clinic
Kyiv, Ukraine, 02091
Medical Center "Consilium Medical"
Kyiv, Ukraine, 04050
Emergency Care Hospital, #1 Therapeutic Department
Lviv, Ukraine, 79059
Regional Hospital, Department of General Surgery
Odesa, Ukraine, 65025
1st City Clinical Hospital, Therapeutic Department
Poltava, Ukraine, 36038
City Clinical Hospital #1, Gastroenterology Department
Vinnytsia, Ukraine, 21029
Medical Centre Diaservis
Zaporizhia, Ukraine, 69076
Sponsors and Collaborators
Kangen Pharmaceuticals, Inc
Investigators
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Principal Investigator: Phiip Hart, MD OSU
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kangen Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02693093    
Other Study ID Numbers: NI03-001
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases