Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
Status:
Completed
Trial end date:
2019-04-23
Target enrollment:
Participant gender:
Summary
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK
of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant
women aged 18-45 followed by a single dose cross over trial evaluating the safety and
pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or
following a high fat meal. The study duration will be approximately 12 months with each
subject participation lasting approximately 6 weeks. In the multiple ascending dose
evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of
eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and
monitored for 7 days from the time of the first dose for predefined adverse events. If there
are no predefined safety events, a second sentinel subject will be enrolled and followed for
a total of 7 days. If there are no predefined safety signals identified for either of these
two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight
subjects have completed the 10 day follow up period, an electronic safety review of the
electronic data will be performed. If none of the predefined safety events have occurred DMID
will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and
will be monitored for a total of 7 days each for predefined adverse events prior to enrolling
the remaining subjects in the group. After the 10 day follow up period has been completed for
group 2, an electronic safety review will be completed and if no predefined events have
occurred two sequential subjects (one at a time with 7 days between each subject) will be
enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be
monitored for a total of 7 days each for predefined safety events prior to enrolling the
remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled
into the single dose cross over group where half of the subjects will initially receive a
single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will
receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then
cross over to receive a single dose following a high fat breakfast or fasting period (water
is permitted). All subjects will have received a dose of oxfendazole following both a fasting
period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole
administered daily for five days; and 2) To assess the safety of oxfendazole administered as
a single dose with or without food.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)