First-in-Human Phase 1 Safety, Pharmacokinetic, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
研究概览
简要总结
This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 40-65 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
- •Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) at screening, and weighing at least 50 kg
- •Nonusers of nicotine-containing products for at least the previous 3 months prior to dosing or nonsmokers
- •Agreement to use birth control during the study and 3 months post last visit.
- •Able to comply with all protocol requirements and procedures
排除标准
- •Clinically significant abnormalities found during physical examinations, medical history review, ECGs (QTcF interval > 450 milliseconds for males and >470 milliseconds for females), vital signs, and laboratory tests (including positive HIV, hepatitis B and C)
- •Participated in in a previous clinical study with an investigational product in the last 60 days
- •History of any serious allergic reaction to any medication
- •Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
- •History of drug or alcohol abuse in the last 2 years
- •Pregnant or lactating women
- •Any other issues which, in the opinion of the PI, will make the subject ineligible for study participation
研究组 & 干预措施
Cohort 1
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 1
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 2
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 2
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 3
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 9 - Food Effect
G1T38
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 3
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 4
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 4
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 5
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 5
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 6
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 6
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 7
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 7
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 8
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 8
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 10
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 10
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 11
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 11
G1T38 or placebo
干预措施: Placebo (Drug)
Cohort 12
G1T38 or placebo
干预措施: G1T38 (CDK 4/6 Inhibitor) (Drug)
Cohort 12
G1T38 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
时间窗: Up to Day 7
All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all subjects receiving study drug through 7 days post dose of study drug.
次要结局
- Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)(Day 1, 2, 3, 4 and 5)
- Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC)(Day 1, 2, 3, 4 and 5)
- Pharmacokinetics of G1T38: Plasma - Volume of distribution(Day 1, 2, 3, 4 and 5)
- Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)(Day 1, 2, 3, 4 and 5)