Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Viread | Placebo Comparator |
| |
| Viread | Active Comparator |
| |
| CMX157 + Viread | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMX157 | Drug | 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. |
|
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Flach, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Madison | Wisconsin | 53704 | United States |
Not provided
| ID | Term |
|---|---|
| C524480 | hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 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. |
|
| Viread | Drug | One single oral dose of 300mg Viread. |
|
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |