Phase 1 open-label, crossover study to evaluate the effect of food on the pharmacokinetics and safety of a single oral dose of PTC518 in healthy volunteers.
- Conditions
- brain diseaseHuntington's disease10029305
- Registration Number
- NL-OMON51584
- Lead Sponsor
- PTC Theraputics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
1. 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 and comply with all protocol requirements.
2. Sex: Male or female
3. Age: 18 to 65 years, inclusive, at Screening.
4. Body mass index (BMI): >=18.0 to 30.0 kg/m2 with a body weight >=50.0 kg for
male subjects and a body weight >=45.0 kg for female subjects at Screening.
5. Healthy as determined by the investigator or designee, based upon a medical
evaluation including medical history, physical examination, laboratory test
results, ECG recording (eg, a corrected QT interval using Fridericia*s formula
[QTcF] <=450 msec for males and QTcF <=470 msec for females), and vital signs at
Screening. Out-of-range values can be repeated once.
Further criteria apply, see protocol.
1. Employee of PRA Health Sciences (PRA) or PTC.
2. History of hypersensitivity reactions to any excipients in the study drug
and/or food allergies.
3. History of malignancy within 5 years, unless one of the following, treated
and considered cured: basal cell carcinoma, in situ cervical cancer, or breast
ductal carcinoma in situ.
4. Previously randomized in this clinical trial.
5. Veins unsuitable for repeated venipuncture or for cannulation.
Further criteria apply, see protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Characterize the effect of food on the PK of PTC518 administered to healthy<br /><br>subjects under fed and fasted conditions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Characterize the safety and tolerability of a single dose of PTC518<br /><br>administered to healthy subjects under fed and fasted conditions.</p><br>