A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- CNTX-6970 Pharmacokinetics - AUC0-inf
研究概览
简要总结
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.
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
- None
盲法说明
Part 1: Open Label Part 2: Double-Blind
入排标准
- 年龄范围
- 18 Years 至 64 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 the Investigator's review
- •Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive
- •For females, is not currently pregnant or breastfeeding 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
- •Has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia
- •Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy
- •Has any history or currently active type of cancer except excised or cured basal cell carcinoma
- •Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs
- •Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine
- •Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease
- •Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment
- •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
- •Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);
- •Is pregnant, lactating, or planning a pregnancy during the study
- •Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)
- •Has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen or naproxen; calcium; or Vitamin D)
- •Use of any of the following:
- •Human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements
- •Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study
研究组 & 干预措施
Part 1 Cohort 1 (Single Dose)
Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)
干预措施: CNTX-6970 (Drug)
Part 1 Cohort 2 (Single Dose)
Single 100 mg oral dose of CNTX-6970 film-coated tablet
干预措施: CNTX-6970 (Drug)
Part 2 (Multiple Ascending Dose)
100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet
干预措施: CNTX-6970 (Drug)
Part 2 Placebo
Placebo oral tablet
干预措施: Placebo (Other)
结局指标
主要结局
CNTX-6970 Pharmacokinetics - AUC0-inf
时间窗: Up to Day 13
Systemic exposure to CNTX-6970 measured by AUC0-inf
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
时间窗: Up to Day 3
Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
CNTX-6970 Pharmacokinetics - AUC0-t
时间窗: Up to Day 13
Systemic exposure to CNTX-6970 measured by AUC0-t
CNTX-6970 Pharmacokinetics - Cmax
时间窗: Up to Day 13
Systemic exposure to CNTX-6970 measured by Cmax
CNTX-6970 Pharmacokinetics - tmax
时间窗: Up to Day 13
Systemic exposure to CNTX-6970 measured by tmax
CNTX-6970 Pharmacokinetics - t1/2
时间窗: Up to Day 13
Systemic exposure to CNTX-6970 measured by t1/2
次要结局
- CNTX-6970 Pharmacodynamics - PD tmax(Up to Day 13)
- Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)(Up to Day 13)
- CNTX-6970 Pharmacodynamics - Emax(Up to Day 13)