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

Crinetics Australia Pty Ltd0 个研究点目标入组 18 人开始时间: 2022年5月16日最近更新: 2023年3月27日

适应症

试验速览

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•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

•- 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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