A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CNTX-6016 in Healthy Subjects and a Single Cohort of Subjects With Painful Diabetic Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- CNTX-6016 Pharmacokinetics - t1/2
研究概览
简要总结
A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is in good general health as determined by Investigator's review.
- •Has a body mass index (BMI) between 18 and 35 kg/m
- •Non- or ex-smoker (> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
- •For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.
- •For males, must agree to use barrier contraception and not to donate sperm
排除标准
- •Is pregnant, lactating, or planning a pregnancy during the study.
- •Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
- •History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
- •Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
- •Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.
- •Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse
- •Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •Key Inclusion Criteria- PDN Cohort
- •A diagnosis/history of Type 2 diabetes mellitus
- •The pain is present in both feet/legs with symmetrical onset
- •The pain is characterized as burning, painful, cold or electrical shocks in nature
- •The pain is associated with tingling, numbness, itching or pins and needles type sensations
- •The pain has been present and consistent for ≥ 6 months
- •Key Exclusion Criteria- PDN Cohort
- •Diagnosis of Type 1 diabetes
- •Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness
- •Has a history or currently active type of cancer except excised or cured basal cell carcinoma.
- •Has a History of psychological conditions or neurological disorders
- •Has a History of lower back pain with radiculopathy
- •Has received non-pharmacological treatment for pain within 14 days
- •Has a history of frequent and/or severe allergic reactions with multiple medications
研究组 & 干预措施
Cohort 1
Dose 1
干预措施: Oral dose CNTX-6016 or oral dose Placebo (Drug)
Cohort 2
Dose 2
干预措施: Oral dose CNTX-6016 or oral dose Placebo (Drug)
Cohort 3
Dose 3
干预措施: Oral dose CNTX-6016 or oral dose Placebo (Drug)
PDN cohort
Dose based on safety in healthy Cohorts 1-3
干预措施: Oral dose CNTX-6016 or oral dose Placebo (Drug)
结局指标
主要结局
CNTX-6016 Pharmacokinetics - t1/2
时间窗: Up to Day 6
Systemic exposure to CNTX-6016 measured by t1/2
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
时间窗: Up to 45 days
Number of participants with TEAEs, which includes laboratory test variables
CNTX-6016 Pharmacokinetics - Cmax
时间窗: Up to Day 6
Systemic exposure to CNTX-6016 measured by Cmax
CNTX-6016 Pharmacokinetics - AUC0-t
时间窗: Up to Day 6
Systemic exposure to CNTX-6016 measured by AUC0-t
CNTX-6016 Pharmacokinetics - tmax
时间窗: Up to Day 6
Systemic exposure to CNTX-6016 measured by tmax
次要结局
未报告次要终点