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NCT03035760 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03035760 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants.
The verdict
NCT03035760, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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
Interventions
- DRUG Oxfendazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2017-05-12 |
| Est. Completion | 2019-04-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03035760
The ClinicalTrials.gov registry entry for NCT03035760 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxfendazole is the first listed.
NCT03035760 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03035760 about?
NCT03035760 is a clinical study titled "Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers". 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 ...
What is the current status of trial NCT03035760?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2017-05-12. Estimated completion is 2019-04-23.
What interventions are being tested in trial NCT03035760?
The interventions under investigation include: Oxfendazole (DRUG).
Who is sponsoring clinical trial NCT03035760?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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