ACTRN12622000704796已完成1 期
A Phase 1, Open-label, Multi-Period, Single Sequence Study to Evaluate the Relative Bioavailability, Performance, and Safety of Two Solid Oral Doses (Paltusotine Tablets) in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Male and female subjects 18 to 65 years of age
- •-BMI 18 to 30 kg/m2
- •- Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or must agree to use a highly effective or two clinically acceptable methods of contraception for the duration of the study and for 30 days after the last study visit.
- •- Male subjects must use a condom and his female partner of childbearing potential must use a highly effective or clinically acceptable form of contraception for the duration of the study and until at least 3 months after the last dose of study drug. Male subjects must also agree to not donate sperm for the duration of the study and until at least 3 months after the last dose of study drug.
- •-Willing to provide signed informed consent
排除标准
- •- Prior treatment with paltusotine.
- •- Any uncontrolled or active major systemic disease.
- •- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years.
- •- Active acute or chronic infection.
- •- Had an unstable psychological disorder less than or equal to 1 year before screening based on the subject’s medical history.
- •- Had a medically significant illness within 30 days of admission.
- •- Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer prior to the first dosing of study drug.
- •- Use of any prior medication without approval of the Investigator within 14 days prior to admission.
- •- History of or current alcohol abuse.
- •- Heavy use of Tobacco and/or nicotine products.
- •- Taking moderate or strong CYP3A4 inhibitors or inducers.
- •- Poor CYP2C19 metabolizers, or ultrarapid metabolizers as determined from blood sample collected during Screening.
- •- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in the study.
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