Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
Status:
Completed
Trial end date:
2015-11-24
Target enrollment:
Participant gender:
Summary
The objectives of the Phase I study are to evaluate the safety and tolerance of increasing
single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the
pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The
description of agent used is single oral dose of an aqueous suspension of oxfendazole, a
benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two
week safety data for the preceding group have been reviewed. If a clinically significant AE
is observed, and if this event is drug-related the safety monitoring committee will be
convened to determine whether the study should continue.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)