drugset / Trial / NCT04920292
PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets
Phase 1
Completed
30 enrolled
Swiss Tropical & Public Health Institute
Drugs for Neglected Diseases · collabIfakara Health Institute · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.
Timeline
- Start
- 2022-04-21
- Primary completion
- 2022-11-07
- Completion
- 2022-11-14
Publications
- Jongo S, Ackermann E, Nyaulingo G, Mbaraka H, Reus E, Cicconi S, Saxena M, Kassim K, Tumbo A, Rashid MA, Robinson S, Louis M, Satam V, Rocha FBDS, Scandale I, Assmus F, Keiser J, Specht S. Pharmacokinetics, safety, and tolerability of an oxfendazole tablet formulation: a phase 1, randomized, placebo-controlled trial in healthy African volunteers. Antimicrob Agents Chemother. 2026 Apr;70(4):e0131525. doi: 10.1128/aac.01315-25. Epub 2026 Feb 18.
- Assmus F, Adehin A, Hoglund RM, Nyaulingo G, Mbarak H, Jongo S, Ackermann E, Reus E, Keiser J, Rocha FBDS, Specht S, Scandale I, Tarning J. Repurposing Oxfendazole for Onchocerciasis: Population Pharmacokinetics of a Tablet Formulation in Healthy African Adults. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70189. doi: 10.1002/psp4.70189.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxfendazole | Small molecule | 100 mg | Oral |
| Subject | Oxfendazole | Small molecule | 400 mg | Oral |