- Healthy male and/or female subjects of non-childbearing potential 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.
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Subjects willing to avoid tanning beds and sun exposure of the back during the study.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of application).
- Subjects with any active skin condition at the application site possibly affecting
drug absorption (e.g. rash, sun burn, scars, tattoos).
- Subjects with a Draize score >0 of the test area (back) immediately prior to first
- Subjects using topical prescription or nonprescription drugs/over the counter
preparations on the back within 14 days of the first treatment application.
- Subjects not willing to avoid application of treatmentssuch as lotions or creams to
the back throughout the study until follow-up.