A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate Relative Oral Bioavailability of 2 Formulations of PTC857 When Administered as a Single Dose to Healthy Subjects - Crossover study to assess relative bioavailability of 2 formulations PTC857

PTC Therapeutics, Inc.0 个研究点目标入组 16 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Males or females aged between 18 and 55 years old and have a body mass index
•(BMI) between 18.5 and 30 kg/m2 (inclusive at Screening as well).
•2. Subjects must understand the nature of the study and must provide signed and
•dated written informed consent before the conduct of any study-related
•procedures.
•3. Females must be either postmenopausal for >=1 year or surgically sterile
•(having undergone tubal ligation, hysterectomy, or bilateral oophorectomy) for
•at least 6 months or, if of childbearing potential and not abstinent, willing
•to use a highly effective method of contraception from Screening through 90
•days after the last dose of study drug. For a detailed breakdown of the birth
•control methods which may be considered as highly effective as well as the
•acceptable birth control methods which may not be considered as highly
•effective, refer to Section 11.4 and Section 11.5, respectively (Appendices).
•4. Females who are abstinent will not be required to use a contraceptive method
•unless they become sexually active.
•5. Women of childbearing potential who are using hormonal contraception should
•also employ, together with their male partner, at least one barrier method.
•6. Females must refrain from ova (egg cell) donation during this time period.

•1. History of coagulopathy.
•2. History of fat malabsorption.
•3. Dietary restrictions that preclude participation.
•4. History of allergies or adverse reactions to PTC857 or to any excipients in
•the study drug formulation.
•5. Females who are pregnant or nursing.
•6. Subjects with a prior medical history of clinically significant
•gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine,
•oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or
•any other condition which, in the opinion of the Investigator, would jeopardize
•the safety of the subject or impact the validity of the study results.

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