Parkinson's Disease
Conditions
Interventions
Subjects will receive PTC857 twice: the new formulation once and the current
formulation once. The order in which they receive the formulations will be
determined by chance. The first dose will be g
Sponsors
PTC Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess the relative bioavailability of PTC857 following a single oral administration of the new (Phase 2) formulation compared to current (Phase 1) formulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to assess the safety and tolerability of PTC857 after administration of single doses of the new and current formulations under fed (medium fat) conditions in healthy adult subjects. | — |
Countries
Netherlands
Outcome results
None listed