An Early Phase 1 interventional study of Ivermectin and Placebo in Ivermectin, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by University of Georgia · Early Phase 1, Interventional, and Basic science
We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts with the human innate immune system and that this contributes to its anti-parasitic effects. Participants will donate blood before and after being administered the normal human dose of the drug. We will compare the cell types present in the blood and the chemicals known to influence the human immune system before and after the drug is given, as well as measuring any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.
Subjects will visit the University of Georgia (UGA) Clinical \& Translation Research Unit (CTRU) twice on consecutive days and blood will be drawn from them. On the first occasion they will be weighed and will complete the consent process. They will have been randomly assigned to the test (Stromectol) or control (placebo) group, with 8 participants in the test group and 4 participants in the control group. Stromectol will be obtained from a medical supply distributor and a placebo will be obtained through the UGA School of Pharmacy. Drugs will be prescribed by Jonathan Murrow MD. They will be stored in their original packaging at room temperature in a drug locker in the lab at CTRU. Participants will be identified by number and allocated to groups using a block randomization protocol. Randomization and drug dispensation will be done by CTRU. Eighteen ml of blood will drawn in a fasting state and they will be administered 150 mcg/kg Stromectol or the equivalent number of placebo tablets immediately after blood is drawn. Participants will remain at CTRU for four hours after they take the drug, then another 15ml of blood will be drawn. On the second day they will attend CTRU at the same time and the third blood sample will be drawn 24 hrs after administration of the drug. On each occasion the drawn blood will be coded by CTRU staff prior to being collected by a member of the Department of Infectious Diseases and taken to the laboratory (Wildlife Health G0007) for the isolation of leukocyte populations (peripheral monocytes, lymphocytes and polymorphonuclear cells (PMNs)) and for the preparation of serum. Complete blood counts will also be carried out. Sera will be analyzed on the Luminex for cytokine/chemokine content. RNA will be isolated from the cell populations for RNASeq analysis.
Exclusion Criteria:
Ivermectin will be administered once at 150mcg/kg, orally.
Drug: Ivermectin
An oral placebo will be administered once
Other: Placebo
150 mcg/kg ivermectin, by mouth.
An oral placebo will be administered, once
The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.
Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=\<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual participants.
Time frame: Pre-treatment, 4 hours and 24 hours post-treatment
Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.
Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.
Time frame: Pre-treatment, 4 hours and 24 hours post-treatment
Complete Blood Counts (CBC)
CBCs will be performed before treatment and 24 hrs later
Time frame: Pre-treatment (0hrs), 24 hours
| Milestone | Ivermectin | Control |
|---|---|---|
| Started | 8 | 4 |
| Completed | 8 | 4 |
| Not completed | 0 | 0 |
Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=\<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual participants.
| Cytokines changed from t=0 | Ivermectin 4hrs | Ivermectin 24 Hrs | Control 4 Hrs | Control 24 Hrs |
|---|---|---|---|---|
| The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded. | 0 | 0 | 0 | 0 |
Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.
| Transcripts signicantly changed from t=0 | Ivermectin 4hrs | Ivermectin 24 Hrs | Control 4 Hrs | Control 24 Hrs |
|---|---|---|---|---|
| Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels. | 0 | 0 | 10 | 0 |
CBCs will be performed before treatment and 24 hrs later
| Million cells/mL | Ivermectin 0 Hrs | Ivermectin 24 Hrs | Control 0 Hrs | Control 24 Hrs |
|---|---|---|---|---|
| Neutrophils | 3.069 ± 0.353 | 3.341 ± 0.426 | 2.940 ± 0.18 | 3.358 ± 0.47 |
| Lymphocytes | 1.753 ± 0.22 | 1.864 ± 0.151 | 1.833 ± 0.161 | 2.075 ± 0.175 |
| Monocytes | 0.483 ± 0.045 | 0.403 ± 0.057 | 0.373 ± 0.04 | 0.375 ± 0.034 |
| Eosinophils | 0.208 ± 0.055 | 0.205 ± 0.047 | 0.158 ± 0.015 | 0.170 ± 0.018 |
| Basophils | 0.04 ± 0.008 | 0.046 ± 0.006 | 0.048 ± 0.008 | 0.048 ± 0.0005 |
Collected over 1 day following administration of the drug/placebo. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ivermectin | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Control | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Event | Ivermectin | Control |
|---|---|---|
| Minor gastrointestinal upsetGastrointestinal disorders | 1/8 | 1/4 |
| Age, Categorical(Participants) | Ivermectin | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 4 | 12 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ivermectin | Control | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 3 | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Ivermectin | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 6 | 3 | 9 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Ivermectin | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 4 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Ivermectin | Control | Total |
|---|---|---|---|
| United States | 8 | 4 | 12 |
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University of Georgia