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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and the time that it takes to eliminate CMX157 following one oral dose when given to healthy volunteers.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of CMX157 in Healthy Adult Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: CMX157
* Drug: Placebo
* Drug: Viread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo + Viread<br> | Drug: Placebo<br>* One single oral dose of placebo will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the placebo dose.<br>Drug: Viread<br>* One single oral dose of 300mg Viread.<br>|
| Active Comparator: Viread<br> | Drug: Viread<br>* One single oral dose of 300mg Viread.<br>|
| Experimental: CMX157 + Viread<br> | Drug: CMX157<br>* One single oral dose of CMX157 will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the CMX157 dose.<br>Drug: Viread<br>* One single oral dose of 300mg Viread.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs), absolute values and changes over time of clinical chemistry including troponin, hematology, and urinalysis, vital signs (blood pressure (BP) and heart rate), electrocardiogram |  | dosing-28 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration. |  | dosin - 28 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy adult volunteers, Pharmacokinetics