A Phase 1, Randomized, Open-Label, Crossover Study Evaluating the Effect of Food on the Pharmacokinetics of ORIC-114 Tablet Formulation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult subjects.
详细描述
The study will be performed in two parts. Part 1 will assess the effect of food at a lower dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure as a way to ensure the safety of the participating subjects. Part 2 will further assess the food effect at a higher dose of ORIC-114.
If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be conducted upon assessment by the Sponsor.
If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated efficacious clinical dose range based on results from Part 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age
- •Continuous nonsmoker who has not used nicotine and tobacco containing products for at least 30 days
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
- •Able to swallow multiple tablets.
排除标准
- •Mentally or legally incapacitated or has significant emotional problems
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- •History or presence of clinically significant GI disorder (
- •Female subjects of childbearing potential.
- •Positive urine drug screen or alcohol breath test results
- •Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •Lactose intolerant.
研究组 & 干预措施
Part 1 Treatment A
30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
干预措施: ORIC-114 (Drug)
Part 1 Treatment B
30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
干预措施: ORIC-114 (Drug)
Part 2 Treatment A
xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
干预措施: ORIC-114 (Drug)
Part 2 Treatment B
xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
干预措施: ORIC-114 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 14 days
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Apparent plasma terminal elimination half-life (t1/2)
时间窗: 14 days
Food Effect: PK of ORIC-114 tablet
Time of maximum observed concentration (Tmax)
时间窗: 14 days
Food Effect: PK of ORIC-114 tablet
Area under the curve (AUC)
时间窗: 14 days
Food Effect: PK of ORIC-114 tablet
次要结局
- Number of subjects with Treatment Emergent Adverse Effect(30 days)