A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or healthy females of non-child bearing potential
- •Age 18 to 65 years of age
- •Body mass index of 18.0 to 32.0 kg/m^2 and weight between 50 kg and 120 kg, inclusive
排除标准
- •Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
- •History of any drug or alcohol abuse in the past 2 years
- •Current smokers and those who have smoked within the last 12 months
- •Females of childbearing potential
- •Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
- •Current disease requiring treatment with systemic corticosteroids
- •Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients
研究组 & 干预措施
Regimen A
干预措施: ORIC-101 (Drug)
Regimen B
干预措施: ORIC-101 (Drug)
Regimen C
干预措施: ORIC-101 (Drug)
Regimen D
干预措施: ORIC-101 (Drug)
Regimen F
干预措施: ORIC-101 (Drug)
Regimen H
干预措施: ORIC-101 (Drug)
Regimen I
干预措施: ORIC-101 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 96 hours post-final dose
PK of ORIC-101 as single doses
Area under the curve (AUC)
时间窗: 96 hours post-final dose
PK of ORIC-101 as single doses
Number of participants with adverse events
时间窗: 96 hours post-final dose
Safety and tolerability of ORIC-101 as single doses
Number of Participants With Abnormal Laboratory Values
时间窗: 96 hours post-final dose
Safety and tolerability of ORIC-101 as single doses
次要结局
- Number of participants with adverse events(96 hours post-final dose)
- Maximum plasma concentration (Cmax)(96 hours post-final dose)
- Area under the curve (AUC)(96 hours post-final dose)
- Number of Participants With Abnormal Laboratory Values(96 hours post-final dose)