A Study to Evaluate the Safety and Pharmacokinetics of Single Doses of CNTX-6016 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Safety of single doses of CNTX-6016 - TEAEs
研究概览
简要总结
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 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
- •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 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).
- •Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse.
- •Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
研究组 & 干预措施
Cohort 7 Drug
800 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 1 Drug
25 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 2 Drug
50 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 3 Drug
100 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 4 Drug
300 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 5 Drug
450 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 6 Drug
600 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 9 Drug
1000 mg Oral Capsule
干预措施: CNTX-6016 (Drug)
Cohort 8 Fasted
Participant will take 300 mg Oral Capsule in a fasting state, and then fed state.
干预措施: CNTX-6016 (Drug)
Cohort 8 Fed
Participant will take 300 mg Oral Capsule in a fed state, and then fasting state.
干预措施: CNTX-6016 (Drug)
结局指标
主要结局
Safety of single doses of CNTX-6016 - TEAEs
时间窗: Up to 80 days
Information regarding treatment emergent adverse events was collected during each dose cohort.
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects
时间窗: 40 days
Dose Proportionality of a single doses of CNTX-6016 in healthy subjects.
CNTX-6016 Pharmacokinetics - Tmax
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by Tmax.
CNTX-6016 Pharmacokinetics - t1/2
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by t1/2.
CNTX-6016 Pharmacokinetics - AUC 0-inf
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-inf.
CNTX-6016 Pharmacokinetics - AUC 0-t/inf
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-t/inf.
CNTX-6016 Pharmacokinetics - CL/F
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by CL/F.
Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax
时间窗: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax.
Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2
时间窗: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2
Effect of Gender on CNTX-6016 Pharmacokinetics - AUC
时间窗: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC.
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2
Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC
Urinary Excretion
时间窗: Up to 6 days
Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry.
CNTX-6016 Pharmacokinetics - Cmax
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by Cmax.
CNTX-6016 Pharmacokinetics - AUC 0-t
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by AUC 0-t.
CNTX-6016 Pharmacokinetics - Vz/F
时间窗: Up to 40 days
Systemic exposure to CNTX-6016 measured by Vz/F.
Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax
时间窗: Up to 80 days
Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax.
次要结局
- Plasma and Urine Metabolite Mining(5 days)