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
- Conditions
- Parkinson's Disease10029305
- Registration Number
- NL-OMON50852
- Lead Sponsor
- PTC Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study is to assess the relative bioavailability of<br /><br>PTC857 following a single oral administration of the new (Phase 2) formulation<br /><br>compared to current (Phase 1) formulation.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of the study is to assess the safety and tolerability<br /><br>of PTC857 after administration of single doses of the new and current<br /><br>formulations under fed (medium fat) conditions in healthy adult subjects.</p><br>