drugset / Trial / NCT01584362
Single Ascending Dose Safety Study of Oxfendazole
Phase 1
Withdrawn
Johns Hopkins Bloomberg School of Public Health
School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos · collabUniversidad Peruana Cayetano Heredia · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This research is being done to learn about the safety in humans of a medicine that is already used in cows and pigs to treat worms. The medicine may be useful for people who have these or other worms. The medicine will be studied first in healthy people, who will be given a very small amount of the medicine once. If the smallest amount of medicine is found to be safe, a slightly higher amount will be given to a new group of volunteers. The highest amount that will be tested is similar to the amount given to animals. If the medicine can be given safely to healthy people in the planned amounts, a later study will be done in people who have worms to see if the medicine kills the worms.
Timeline
- Start
- 2016-08
- Primary completion
- 2016-08
- Completion
- 2016-08
Publications
- Results Gonzalez AE, Falcon N, Gavidia C, Garcia HH, Tsang VC, Bernal T, Romero M, Gilman RH. Treatment of porcine cysticercosis with oxfendazole: a dose-response trial. Vet Rec. 1997 Oct 18;141(16):420-2. doi: 10.1136/vr.141.16.420.
- Results Gonzales AE, Garcia HH, Gilman RH, Gavidia CM, Tsang VC, Bernal T, Falcon N, Romero M, Lopez-Urbina MT. Effective, single-dose treatment or porcine cysticercosis with oxfendazole. Am J Trop Med Hyg. 1996 Apr;54(4):391-4. doi: 10.4269/ajtmh.1996.54.391.
- Results Gonzalez AE, Falcon N, Gavidia C, Garcia HH, Tsang VC, Bernal T, Romero M, Gilman RH. Time-response curve of oxfendazole in the treatment of swine cysticercosis. Am J Trop Med Hyg. 1998 Nov;59(5):832-6. doi: 10.4269/ajtmh.1998.59.832.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxfendazole | Small molecule | 0.3 mg/kg | Oral |
| Subject | Oxfendazole | Small molecule | 1 mg/kg | Oral |
| Subject | Oxfendazole | Small molecule | 3 mg/kg | Oral |
| Subject | Oxfendazole | Small molecule | 10 mg/kg | Oral |
| Subject | Oxfendazole | Small molecule | 20 mg/kg | Oral |
| Subject | Oxfendazole | Small molecule | 30 mg/kg | Oral |