NCT02693093已完成1 期
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
Kangen Pharmaceuticals, Inc48 个研究点 分布在 3 个国家目标入组 264 人开始时间: 2016年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 48
- 主要终点
- Phase 1 - Safety and Tolerability - Laboratory test results
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of NI-03.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, subjects must meet all of the following criteria at Screening:
- •Males and females aged 18 to 85 years, inclusive, at the time of consent
- •Ability to communicate effectively with clinic site staff, ability and willingness to comply with the study schedule, restrictions, and requirements
- •Institutional Review Board (IRB)-approved written informed consent
- •Diagnosis of chronic pancreatitis
- •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
- •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.
排除标准
- •To be eligible to participate in this study, subjects must not meet any of the following criteria:
- •Any other clinically significant medical condition
- •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
- •Major abdominal surgery within 90 days of Day 1
- •History or presence of clinically significant cardiovascular disease
- •History of any cancer, except non-melanoma skin cancer, within 5 years of study enrollment,
- •History of endoscopic intervention within the previous 3 months or presence of a pancreatic duct stent
- •History of illicit drug abuse (i.e. use of any 'illegal' drugs within 6 months)
- •Active heavy alcohol use (defined as more than 2 alcoholic drinks per day or 14 alcoholic drinks per week)
- •Inadequate venous access
- •Significant blood loss, donation of ≥450 mL of blood, or blood or blood product transfusion within 7 days of Day 1
- •History or presence of hepatitis B (surface antigen positivity), active hepatitis C or human immunodeficiency virus (HIV) antibody
- •Active infection within 30 days of Day 1
- •Pregnant, planning to become pregnant or breast feeding
- •Positive urine or serum pregnancy test result at Screening or on Day 1
- •Active major psychiatric illness requiring a change in treatment within 3 months that would confound pain assessments
- •History of seizures within the last 12 months
- •Current use of anticonvulsants, antipsychotics, systemic steroids and, immunosuppressant therapy. *Use of gabapentin, pregabalin and benzodiazepines as treatment for chronic pancreatitis pain are allowed.
- •Presence of generalized pain syndrome apart from chronic pancreatitis
研究组 & 干预措施
placebo
Placebo Comparator
TID Day for 28 Days
干预措施: Placebo (Drug)
100 mg NI-03
Experimental
TID Day for 28 Days
干预措施: NI-03 (Drug)
200 mg NI-03
Experimental
TID Day for 28 Days
干预措施: NI-03 (Drug)
300 mg NI-03
Experimental
TID Day for 28 Days
干预措施: NI-03 (Drug)
结局指标
主要结局
Phase 1 - Safety and Tolerability - Laboratory test results
时间窗: 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
Phase 1 - To determine the pharmacokinetic profile for FOY251 and GBA
时间窗: 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.
Phase 1 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0
时间窗: through 7 days post-dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Phase 2 - Efficacy Analysis - average daily worst pain intensity score
时间窗: 4 Weeks
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- Phase 2 - Efficacy Analysis - Change from baseline in least pain score(change from baseline to Week 4)
- Phase 2 - Efficacy Analysis - Change from baseline in average pain score(4 Weeks)
- Phase 2 - Efficacy Analysis - Change from baseline in current pain score(4 Weeks)
- Phase 2 - Efficacy Analysis - Change from baseline in average morphine-equivalent daily opioid daily dose(4 Weeks)
- Phase 2 - Efficacy Analysis - Change from baseline in quality of life(change from baseline to Week 4)
- Phase 2 - Safety and Tolerability - Treatment Emergent Adverse Events (TEAE) via CTCAE v4.0(Through day 57 (End of Study Visit))
- Phase 2 - Safety and tolerability - Laboratory Test Results(Through day 57 (End of Study Visit))
- 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)
- 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.)
- 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)
- 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)
- 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)
- 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)
研究者
研究点 (48)
Loading locations...
相似试验
已完成
1 期
A clinical trial of SIIL's H1N1 vaccine (Inactivated) in Adults.CTRI/2010/091/000082Serum Institute of India Limited SII50
招募中
1 期
The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's DiseaseEarly-onset Parkinson's DiseaseNCT06608355iRegene Therapeutics Co., Ltd.6
终止
1 期
Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD)Alzheimer DiseaseNeuro-Degenerative DiseaseNCT04678453NKGen Biotech, Inc.10
进行中（未招募）
1 期
Single Dose Study of MK-2060 in Japanese Older Participants on Dialysisend-stage renal diseaseJPRN-jRCT2041230025Tanaka Yoshiyuki16
已完成
不适用
A single dose clinical trial to study the safety of ART-I02 in patients with arthritisarthritis10003816NL-OMON45686Arthrogen B.V.12