brain disease Huntington's disease
Conditions
Interventions
The volunteer will receive 20 milligram of PTC518 once per period, so in total
2 times.
Sponsors
PTC Theraputics, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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]
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize the effect of food on the PK of PTC518 administered to healthy subjects under fed and fasted conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the safety and tolerability of a single dose of PTC518 administered to healthy subjects under fed and fasted conditions. | — |
Countries
Netherlands
Outcome results
None listed