A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers

Inclusion criteria

• Males or females of non-childbearing potential, 18 to 55 years of age. Males must be able and willing to use adequate contraceptive methods throughout the study.

Exclusion criteria

• Currently nursing females, pregnant females, or females of child-bearing potential.
• Hypersensitivity to tenofovir.
• Use of any antiviral, corticosteroid, immunosuppressive, or anticoagulant prescription drug within 4 weeks prior to enrollment. Use of any other prescription drug within 14 days prior to enrollment.
• Use of any over-the-counter medication, herbal/nutraceutical preparation, within 7 days prior to enrollment.
• Administration of any potentially nephrotoxic drug within 14 days prior to enrollment.
• Use of an investigational drug and/or treatment within 30 days prior to enrollment.
• Use of illicit drugs within 6 months prior to screening and enrollment, based on history and a urine drug screen.
• Infection with HIV, HBV or HCV.
• History of abuse of alcohol or other substance (s) within 6 months prior to enrollment.
• History or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease, cardiomyopathy, and cardiac conduction disorders.
• History of clinically significant hypotension (including orthostatic), fainting, or lightheadedness.
• History of gastrointestinal disease or impairment.
• History of renal impairment or disorder.
• History of liver disease or impairment.
• History of cancer, except basal cell carcinoma.
• History of pathologic bone fractures; history or risk of osteopenia
• History of diabetes, metabolic disease, or autoimmune disease; history of immunodeficiency in healthy volunteers.
• Acute illness or fever 38 C within 1 week prior to enrollment.
• Supine blood pressure - systolic outside the range of 90-140 mmHg, or diastolic outside the range of 50-90 mmHg.
• Resting heart rate > 100 or < 45 beats per minute.
• Body Mass Index (BMI) >31 or <18, or body weight <50 kg for men and < 45 kg for women.
• Whole blood donation within 56 days or plasma donation within 30 days prior to enrollment.