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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 : April 20, 2018
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 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.


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 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Contact: Aidan Nuttall, PhD 760 672 2640 aidan.nuttall@stasonpharma.com
Contact: Sarah Anderson 760-405-1377 sarah.anderson@synteracthcr.com

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Sponsors and Collaborators
Stason Pharmaceuticals, Inc.

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: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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