Safety studies in human volunteers
Single ascending dose safety and pharmacokinetics study
ODG members worked with the National Institutes of Health (NIAID/DMID) to conduct First in Human studies of oxfendazole, the first clinical step in the development of oxfendazole. The design and results of this safety and pharmacokinetics study are given under NCT02234570 on the ClinicalTrials.gov web site: https://clinicaltrials.gov/ct2/show/NCT02234570?term=oxfendazole&rank=2 The results of the Phase I Single Ascending Dose (SAD) study of oxfendazole are now published. See the safety profile and pharmacokinetics of oxfendazole in healthy volunteers: publication Phase I SAD study
Multiple ascending dose safety and pharmacokinetics study and food effect study
ODG worked with the National Institutes of Health (NIAID/DMID) to conduct a Multiple Ascending Dose (MAD) study of oxfendazole, as well as a food effect study. Oxfendazole was well tolerated across the range of doses studied, and the consumption of food prior to oxfendazole administration was found to increase oxfendazole plasma levels (Tmax, Cmax, AUC). The design and results of these studies is given under NCT03035760 on the ClinicalTrials.gov web site: https://clinicaltrials.gov/ct2/show/NCT03035760?term=oxfendazole&rank=2 and published: Oxfendazole MAD study 2020.
Population Pharmacokinetic/Pharmacodynamic study
Using the data from the SAD and MAD studies, ODG collaborated with the National Institutes of Health (NIAID/DMID) and the University of Iowa in the elaboration of a population pharmacokinetics and pharmacodynamics (popPK/PD) model of oxfendazole and used to explore target attainment in the treatment of two different parasitic infections trichuriasis and filariasis. This work is just being published: see pop PK/PD pub
Efficacy study in patients
Proof of concept study in patients
ODG is collaborating with NIH/DMID, the Universities of Iowa and Virginia, and the Peruvian nonprofit Asociacion Benefica Prisma to conduct the first study of oxfendazole in patients infected with a Neglected Tropical Disease, Trichuris trichiura, an intestinal worm. In this assessor blind, randomized Phase 2 study, the efficacy of different doses of oxfendazole will be compared to the efficacy of albendazole, the currently used medication. Albendazole is only moderately effective in curing T. trichiura infection. The design of this study is given under NCT04713787 on the Clinicaltrials.gov website: https://clinicaltrials.gov/ct2/show/NCT04713787?term=oxfendazole&draw=2&rank=4