A Phase 1 interventional study of CMX157 and Placebo in Healthy, sponsored by Chimerix. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-04.
Sponsored by Chimerix · Phase 1 and Interventional
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.
Chimerix is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo · Drug: Viread
Drug: Viread
Drug: CMX157 · Drug: Viread
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.
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.
One single oral dose of 300mg Viread.
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
Time frame: dosing-28 days post-dose
CMX157 PK parameters: AUC(0-∞), AUC(0-t), Cmax, C12, and C24 following single dose administration.
Time frame: dosin - 28 days post-dose
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Chimerix