Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1 Open Label, Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
Brief Summary: This Phase I study is an open label multiple ascending dose evaluation of the safety and PK of oxfendazole given orally daily to healthy adult men and nonpregnant women aged 18-45 followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a single dose of oxfendazole given following an 8 hour fast or following a high fat meal. The study duration will be approximately 12 months with each subject participation lasting approximately 6 weeks. In the first phase of this study, between 8 and 24 subjects will be enrolled; each dose group will be comprised of 8 volunteers. To enhance safety, one sentinel subject will be dosed for five days and monitored for 7 days from the time of the first dose for predefined adverse events. If there are no predefined safety events, a second sentinel subject will be enrolled and followed for a total of 7 days. If there are no predefined safety signals identified for either of these two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight subjects have completed the 10 day follow up period, a safety review of the electronic data will be performed. If none of the predefined safety events have occurred DMID will approve enrollment into the second dose group and will be monitored for a total of 7 days each for predefined adverse events prior to enrolling the remaining subjects in the group. After the 10 day follow up period has been completed for group 2, a safety review will be completed and if no predefined events have occurred two sequential subjects will be enrolled into the third dose group and will be monitored for a total of 7 days each for predefined safety events prior to enrolling the remaining subjects in the group. In the second phase of the study evaluating the effects of food on drug absorption, 12 subjects will be enrolled into the single dose cross over study where half of the subjects will initially receive a single dose of oxfendazole following an 8 hour fast a