Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages 18-45 volunteers recruited from one site will participate in this study. The study duration is approximately 18 months with subject participation of 2 weeks. The primary objective assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be monitored 48 hours for adverse events prior to completing enrollment of the remaining 8 subjects in the group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02234570
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date November 17, 2014
Completion date November 24, 2015

See also
  Status Clinical Trial Phase
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Terminated NCT02233855 - People Presenting With Neurocysticercosis in North America
Recruiting NCT00001205 - Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Terminated NCT02947581 - Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO) Phase 3
Completed NCT02243644 - Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Phase 3
Not yet recruiting NCT06376396 - Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis Phase 4
Completed NCT03874689 - Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia
Completed NCT00441285 - Neurocysticercosis: Combined Treatment With Praziquantel (PZQ) and Albendazole (ABZ) Phase 2/Phase 3
Not yet recruiting NCT04706819 - Parenchymal and Extraparenchymal Neurocysticercosis-A Registry Based Study
Completed NCT00283699 - A Pilot Study of Neurocysticercosis Treatment Phase 3
Terminated NCT02945527 - Treatment of Peri-calcification Edema in Neurocysticercosis (NCC) Phase 2/Phase 3
Completed NCT00290823 - Corticosteroids to Reduce Frequency of Seizures in Neurocysticercosis Patients Phase 3
Completed NCT03834337 - Treatment of Patients With Active Neurocysticercosis in Eastern Africa
Completed NCT03851419 - The Burden of (Neuro)Cysticercosis Among People Living With HIV in Rural Tanzania