A Phase I, single*center, double-blind, randomized, placebo-controlled, single and multiple ascending dose trial to evaluate the safety and pharmacokinetics of PTC857 in healthy volunteers.
- Conditions
- Parkinson's Disease10007951
- Registration Number
- NL-OMON49571
- Lead Sponsor
- PTC Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
Healthy male or female subjects aged from 18 to 55 years old, inclusive, at
Screening.
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.
BMI of * 19.0 kg/m2 and * 35.0 kg/m2 with a body weight * 50.0 kg for male
subjects and a body weight * 45.0 kg for female subjects at Screening.
Healthy as determined by the Investigator, based upon a medical evaluation
including medical history, physical examination, laboratory tests, triplicate
ECG recording (average QTcF * 450 msec) and vital signs. Out of range values
can be repeated once.
History of coagulopathy.
History of fat malabsorption.
Dietary restrictions that preclude participation.
Females who are pregnant or nursing.
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
- Secondary Outcome Measures
Name Time Method