This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Step 3/Cohort J: AMD11070/Ritonavir (RTV) Interaction This is a phase I, open-label, multiple dose, and sequential design drug interaction study that will consist of one cohort of healthy volunteers. Volunteers will be dosed initially with 200 mg AMD11070 alone on Day 1. On Days 1-3 blood samples will be taken for analysis of AMD11070 concentration (AMD11070 alone phase). Volunteers will not receive any drug on Day 2 to allow clearance of nearly all (estimated to be > 93%) of the first AMD11070 dose. On Day 3, volunteers will begin taking RTV (100 mg bid) through Day 18 (for a total of 16 consecutive days, 32 total doses). A single 200-mg dose of AMD11070 will also be given simultaneously with the morning RTV dose on Day 3. On Days 3-5, frequent blood samples will be taken for PK analysis of AMD11070 and RTV concentrations (acute RTV phase). There will be blood collection to measure RTV levels within 6 hours after dosing on Day 10 or 11. On Day 17, volunteers will receive another 200-mg dose of AMD11070 simultaneously with their morning RTV dose. The evening RTV dose on Day 18 will be the last dose. On Days 17-19, blood samples will again be taken for analysis of AMD11070 and RTV concentrations (steady-state RTV phase). Safety of AMD11070 alone and during co-administration with RTV will be assessed throughout the study period. Coadministration of low-dose ritonavir (RTV) will increase the AMD11070 PK exposure. AMD11070 will not affect the RTV PK exposure.
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