- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
(Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG and clinical laboratory tests). Female subjects will be of
non-childbearing potential.
- An informed consent document signed and dated by the subject or a legally acceptable
representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
allergic, (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing), muscle disease, diabetes, or severe uncontrolled
hypertension.
- Any significant bleeding diathesis which could preclude recovery from the biopsy
procedure. ASA, ibuprofen, and any other oral anti platelet agent should be
discontinued at least 7 days prior to procedure.
- Prothrombin time (PT)/INR and/or activated partial thromboplastin time (aPTT) above
the respective local laboratory normal ranges.
- Abnormal CK as per CRU laboratory ranges.
- Subjects with either a medical history of or physical evidence of keloid scar
formation upon physical examination.
- 12 lead ECG demonstrating a clinically significant abnormality.
- Females of child bearing potential, pregnant or nursing females or females less than 6
months postpartum from the scheduled date of collection.
- Known hypersensitivity to lidocaine or any component of the study procedure.
- Participation in non-routine rigorous exercise (eg, road races, heavy lifting, etc.)
within one week prior to the muscle biopsy procedures.
- Professional athletes.