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

Sponsor
Kangen Pharmaceuticals, Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02693093
Collaborator
(none)
260
48
4
70
5.4
0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 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 :
Dec 1, 2015
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA [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 [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 [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 [4 Weeks]

Secondary Outcome Measures

  1. Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA -area under the curve (AUC) [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) [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) [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) [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) [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) [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 [change from baseline to Week 4]

  8. Phase 2 - Efficacy Analysis - Change from baseline in average pain score [4 Weeks]

  9. Phase 2 - Efficacy Analysis - Change from baseline in current pain score [4 Weeks]

  10. Phase 2 - Efficacy Analysis - Change from baseline in average morphine-equivalent daily opioid daily dose [4 Weeks]

  11. Phase 2 - Efficacy Analysis - Change from baseline in quality of life [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 [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 [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) [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) [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) [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) [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) [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) [Days 1 and 29, and at 0.25, 0.5, 1, 2 and 4 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas Little Rock Arkansas United States 72204
2 Kaiser Permanente Medical Group Los Angeles California United States 90027
3 University of Southern California, Keck School of Medicine Los Angeles California United States 90033
4 Stanford University School of Medicine Stanford California United States 94305
5 University of Colorado-Div of Gastroenterology and Hepatology Aurora Colorado United States 80045
6 Yale School of Medicine New Haven Connecticut United States 06519
7 University of Florida - Division of Gastroenterology Gainesville Florida United States 32608
8 Borland-Groover Clinic Jacksonville Florida United States 32256
9 Gastroenterology Group of Naples Naples Florida United States 34102
10 The Carle Foundation Hospital Urbana Illinois United States 61801
11 Indiana University - Indiana University Hospital Indianapolis Indiana United States 46202-5149
12 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
13 UMass Memorial Medical Center Worcester Massachusetts United States 01605
14 Clinical Research Institute of Michigan, LLC Chesterfield Michigan United States 48047
15 Gastroenterology Associates of Western Michigan Wyoming Michigan United States 49519
16 Kansas City Research Institute Kansas City Missouri United States 64131
17 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
18 Columbia University School of Medicine New York New York United States 10027
19 PMG Research of Winston-Salem Winston-Salem North Carolina United States 27103
20 MetroHealth Medical Center Cleveland Ohio United States 44109
21 Ohio State University (OSU) - Wexner Medical Center Columbus Ohio United States 43210
22 UPMC Presbyterian Pittsburgh Pennsylvania United States 15213-2536
23 Medical University of South Carolina (MUSC) Charleston South Carolina United States 29425
24 Texas Clinical Research Institute Arlington Texas United States 76012
25 Texas Tech University Health Sciences Center El Paso Texas United States 79905
26 Baylor College of Medicine Houston Texas United States 77030
27 Virginia Mason Seattle Washington United States 98101
28 Wisconsin Center for Advanced Research, a division of GI Associates LLC Milwaukee Wisconsin United States 53215
29 Federal Research Centre Institute of Cytology and Genetics Novosibirsk Russian Federation 630089
30 Military Medical Academu, Dep of Therapy of Adv. Training Saint Petersburg Russian Federation 191015
31 Military Medical Academy, Department of Hospital Therapy Saint Petersburg Russian Federation 191124
32 1st Saint Petersburg State Medical University Saint Petersburg Russian Federation 197022
33 City Hospital #40 Saint Petersburg Russian Federation 197706
34 City Polyclinic #4 Saint Petersburg Russian Federation 199178
35 Medical University "Reaviz" Samara Russian Federation 443011
36 Tomsk Regional Clinical Hospital Tomsk Russian Federation 634063
37 Institute of Gastroenterology Dnipro Ukraine 49074
38 Central city Clinical Hospital, Therapeutic Department #2 Ivano-Frankivsk Ukraine 76018
39 Malaya Therapy National Institute Kharkiv Ukraine 61039
40 City Policlinic #9 Kharkiv Ukraine 61172
41 City Hospital Named After Tropins, Therapy Department #1 Kherson Ukraine 73000
42 OK Clinic Kyiv Ukraine 02091
43 Medical Center "Consilium Medical" Kyiv Ukraine 04050
44 Emergency Care Hospital, #1 Therapeutic Department Lviv Ukraine 79059
45 Regional Hospital, Department of General Surgery Odesa Ukraine 65025
46 1st City Clinical Hospital, Therapeutic Department Poltava Ukraine 36038
47 City Clinical Hospital #1, Gastroenterology Department Vinnytsia Ukraine 21029
48 Medical Centre Diaservis Zaporizhia Ukraine 69076

Sponsors and Collaborators

  • Kangen Pharmaceuticals, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kangen Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT02693093
Other Study ID Numbers:
  • NI03-001
First Posted:
Feb 26, 2016
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021