A Phase 1, Multi-Cohort, Single Dose Study to Assess The Relative Bioavailability, Performance, and Safety of Two Novel Formulations of CRN00808

Crinetics Australia Pty Ltd0 个研究点目标入组 57 人开始时间: 2019年11月13日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•Male and female subjects 18 to 55 years of age (Cohorts 1, 2 and 4)
•- Male and Female subjects 18 to 65 years of age (Cohort 3 and 5)
•- BMI 18 to 30 kg/m2
•- Females must be non-pregnant and non-lactating, and either surgically sterile, post- menopausal, or using effective method(s) of birth control
•- male subjects must use a condom, or his female partner of childbearing potential must use an effective form of contraception. 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

•- Prior treatment with CRN00808
•- 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
•- Use of any investigational drug within the past 60 days
•- 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
•- Taking moderate or strong CYP3A4 inhibitors or inducers.
•- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in the study

发起方