Trial Outcomes & Findings for Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole (NCT NCT02234570)
NCT ID: NCT02234570
Last Updated: 2020-11-02
Results Overview
All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as "there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
70 participants
Primary outcome timeframe
Within 14 Days of first dose
Results posted on
2020-11-02
Participant Flow
Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical site. Participants were enrolled between 17NOV2014 and 09NOV2015.
Participant milestones
| Measure |
0.5 mg/kg Oxfendazole
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
14
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
8
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
Baseline characteristics by cohort
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
n=14 Participants
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
70 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
23.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
26.8 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
22.6 years
STANDARD_DEVIATION 6.7 • n=8 Participants
|
24.6 years
STANDARD_DEVIATION 8.0 • n=8 Participants
|
26.9 years
STANDARD_DEVIATION 7.2 • n=24 Participants
|
25.6 years
STANDARD_DEVIATION 7.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
67 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
61 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
57 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
14 participants
n=24 Participants
|
70 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Within 14 Days of first dosePopulation: All participants are included in the analysis population.
All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as "there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
n=14 Participants
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dosePopulation: All participants receiving oxfendazole are included in the analysis population.
AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole
|
11682.4 ng•hr/mL
Geometric Coefficient of Variation 44.8
|
13117.7 ng•hr/mL
Geometric Coefficient of Variation 54.4
|
30803.1 ng•hr/mL
Geometric Coefficient of Variation 20.1
|
73928.9 ng•hr/mL
Geometric Coefficient of Variation 40.6
|
99542.6 ng•hr/mL
Geometric Coefficient of Variation 23.9
|
78344.0 ng•hr/mL
Geometric Coefficient of Variation 34.4
|
108618.2 ng•hr/mL
Geometric Coefficient of Variation 38.4
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dosePopulation: All participants receiving oxfendazole are included in the analysis population.
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma
|
943.9 ng/mL
Geometric Coefficient of Variation 28.4
|
1155.9 ng/mL
Geometric Coefficient of Variation 26.8
|
2436.9 ng/mL
Geometric Coefficient of Variation 24.0
|
4781.3 ng/mL
Geometric Coefficient of Variation 25.6
|
6254.8 ng/mL
Geometric Coefficient of Variation 21.7
|
5301.3 ng/mL
Geometric Coefficient of Variation 30.5
|
6768.4 ng/mL
Geometric Coefficient of Variation 31.3
|
—
|
SECONDARY outcome
Timeframe: Day 1-Day15Population: All participants receiving oxfendazole are included in the analysis population
Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations \<LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Concentrations of Oxfendazole Fenbendazole
1 Hour
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0.3 ng/mL
Standard Deviation 0.8
|
0.3 ng/mL
Standard Deviation 0.7
|
1.0 ng/mL
Standard Deviation 1.4
|
1.4 ng/mL
Standard Deviation 1.2
|
5.9 ng/mL
Standard Deviation 2.4
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
2 Hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0.4 ng/mL
Standard Deviation 0.8
|
1.1 ng/mL
Standard Deviation 1.5
|
2.6 ng/mL
Standard Deviation 2.5
|
2.2 ng/mL
Standard Deviation 1.5
|
6.3 ng/mL
Standard Deviation 2.5
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
4 Hours
|
0.6 ng/mL
Standard Deviation 1.8
|
0.8 ng/mL
Standard Deviation 1.1
|
3.5 ng/mL
Standard Deviation 2.5
|
3.0 ng/mL
Standard Deviation 3.2
|
8.1 ng/mL
Standard Deviation 8.0
|
4.4 ng/mL
Standard Deviation 4.3
|
8.0 ng/mL
Standard Deviation 3.6
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
6 Hours
|
0.5 ng/mL
Standard Deviation 1.3
|
2.0 ng/mL
Standard Deviation 1.4
|
4.8 ng/mL
Standard Deviation 2.9
|
6.6 ng/mL
Standard Deviation 4.8
|
9.9 ng/mL
Standard Deviation 8.3
|
5.8 ng/mL
Standard Deviation 6.7
|
12.4 ng/mL
Standard Deviation 4.9
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
8 Hours
|
0.3 ng/mL
Standard Deviation 0.9
|
1.9 ng/mL
Standard Deviation 1.2
|
5.2 ng/mL
Standard Deviation 2.9
|
6.7 ng/mL
Standard Deviation 4.6
|
10.8 ng/mL
Standard Deviation 8.3
|
5.0 ng/mL
Standard Deviation 5.1
|
15.5 ng/mL
Standard Deviation 8.6
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
10 Hours
|
0.3 ng/mL
Standard Deviation 0.8
|
2.3 ng/mL
Standard Deviation 1.2
|
6.8 ng/mL
Standard Deviation 2.6
|
10.0 ng/mL
Standard Deviation 5.7
|
11.2 ng/mL
Standard Deviation 6.6
|
5.5 ng/mL
Standard Deviation 4.5
|
18.4 ng/mL
Standard Deviation 11.1
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
12 Hours
|
0.3 ng/mL
Standard Deviation 0.9
|
2.3 ng/mL
Standard Deviation 1.4
|
6.7 ng/mL
Standard Deviation 2.4
|
10.1 ng/mL
Standard Deviation 5.5
|
11.7 ng/mL
Standard Deviation 7.9
|
6.4 ng/mL
Standard Deviation 4.5
|
20.9 ng/mL
Standard Deviation 19.0
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
24 Hours
|
0.7 ng/mL
Standard Deviation 1.0
|
2.3 ng/mL
Standard Deviation 1.6
|
7.1 ng/mL
Standard Deviation 2.5
|
4.9 ng/mL
Standard Deviation 4.0
|
10.0 ng/mL
Standard Deviation 3.7
|
5.4 ng/mL
Standard Deviation 3.2
|
16.7 ng/mL
Standard Deviation 12.9
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
Day 3
|
0.4 ng/mL
Standard Deviation 0.5
|
0.9 ng/mL
Standard Deviation 0.4
|
3.2 ng/mL
Standard Deviation 2.8
|
2.2 ng/mL
Standard Deviation 1.7
|
3.7 ng/mL
Standard Deviation 3.4
|
2.5 ng/mL
Standard Deviation 3.1
|
5.5 ng/mL
Standard Deviation 4.2
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
Day 4
|
0.4 ng/mL
Standard Deviation 0.5
|
0.9 ng/mL
Standard Deviation 0.4
|
1.1 ng/mL
Standard Deviation 0.4
|
1.4 ng/mL
Standard Deviation 1.0
|
1.2 ng/mL
Standard Deviation 0.6
|
1.3 ng/mL
Standard Deviation 1.4
|
2.5 ng/mL
Standard Deviation 3.0
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
Day 6
|
0.4 ng/mL
Standard Deviation 0.5
|
0.9 ng/mL
Standard Deviation 0.4
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
0.9 ng/mL
Standard Deviation 0.4
|
1.7 ng/mL
Standard Deviation 1.9
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
Day 8
|
0.4 ng/mL
Standard Deviation 0.5
|
0.9 ng/mL
Standard Deviation 0.4
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
0.9 ng/mL
Standard Deviation 0.4
|
1.0 ng/mL
Standard Deviation 0.0
|
—
|
|
Plasma Concentrations of Oxfendazole Fenbendazole
Day 15
|
0.4 ng/mL
Standard Deviation 0.5
|
0.9 ng/mL
Standard Deviation 0.4
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
0.9 ng/mL
Standard Deviation 0.4
|
1.0 ng/mL
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: Day 1-Day15Population: All participants receiving oxfendazole are included in the analysis population
Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations \<LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Plasma Concentrations of Oxfendazole Sulfone
1 Hour
|
28.5 ng/mL
Standard Deviation 4.6
|
31.1 ng/mL
Standard Deviation 11.1
|
73.0 ng/mL
Standard Deviation 24.1
|
100.5 ng/mL
Standard Deviation 25.4
|
111.6 ng/mL
Standard Deviation 51.9
|
161.5 ng/mL
Standard Deviation 41.3
|
209.1 ng/mL
Standard Deviation 84.5
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
2 Hours
|
48.7 ng/mL
Standard Deviation 9.3
|
56.0 ng/mL
Standard Deviation 11.3
|
106.3 ng/mL
Standard Deviation 31.5
|
182.3 ng/mL
Standard Deviation 51.6
|
219.2 ng/mL
Standard Deviation 73.0
|
262.6 ng/mL
Standard Deviation 72.5
|
319.0 ng/mL
Standard Deviation 119.9
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
4 Hours
|
52.3 ng/mL
Standard Deviation 8.6
|
67.6 ng/mL
Standard Deviation 16.0
|
108.1 ng/mL
Standard Deviation 25.7
|
223.8 ng/mL
Standard Deviation 62.5
|
258.6 ng/mL
Standard Deviation 73.0
|
285.7 ng/mL
Standard Deviation 74.5
|
345.4 ng/mL
Standard Deviation 133.0
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
6 Hours
|
57.3 ng/mL
Standard Deviation 15.1
|
75.1 ng/mL
Standard Deviation 26.6
|
113.8 ng/mL
Standard Deviation 26.2
|
264.1 ng/mL
Standard Deviation 63.0
|
308.3 ng/mL
Standard Deviation 98.8
|
330.3 ng/mL
Standard Deviation 90.1
|
404.6 ng/mL
Standard Deviation 154.7
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
8 Hours
|
59.7 ng/mL
Standard Deviation 13.7
|
78.2 ng/mL
Standard Deviation 27.0
|
135.5 ng/mL
Standard Deviation 33.9
|
296.2 ng/mL
Standard Deviation 71.5
|
336.8 ng/mL
Standard Deviation 72.2
|
356.3 ng/mL
Standard Deviation 120.1
|
454.8 ng/mL
Standard Deviation 174.0
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
10 Hours
|
62.8 ng/mL
Standard Deviation 22.3
|
70.7 ng/mL
Standard Deviation 28.5
|
119.4 ng/mL
Standard Deviation 18.7
|
308.7 ng/mL
Standard Deviation 120.1
|
340.8 ng/mL
Standard Deviation 68.1
|
352.4 ng/mL
Standard Deviation 106.0
|
470.7 ng/mL
Standard Deviation 182.5
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
12 Hours
|
56.8 ng/mL
Standard Deviation 17.5
|
65.4 ng/mL
Standard Deviation 30.9
|
111.4 ng/mL
Standard Deviation 12.4
|
296.0 ng/mL
Standard Deviation 90.3
|
359.3 ng/mL
Standard Deviation 102.1
|
343.7 ng/mL
Standard Deviation 111.7
|
487.7 ng/mL
Standard Deviation 210.3
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
24 Hours
|
30.9 ng/mL
Standard Deviation 23.4
|
38.9 ng/mL
Standard Deviation 31.7
|
68.5 ng/mL
Standard Deviation 21.0
|
176.7 ng/mL
Standard Deviation 125.5
|
261.8 ng/mL
Standard Deviation 83.4
|
185.2 ng/mL
Standard Deviation 90.5
|
362.2 ng/mL
Standard Deviation 222.7
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
Day 3
|
11.4 ng/mL
Standard Deviation 11.8
|
11.1 ng/mL
Standard Deviation 10.3
|
20.8 ng/mL
Standard Deviation 12.2
|
64.8 ng/mL
Standard Deviation 94.9
|
75.1 ng/mL
Standard Deviation 47.6
|
57.5 ng/mL
Standard Deviation 54.4
|
119.5 ng/mL
Standard Deviation 86.8
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
Day 4
|
3.6 ng/mL
Standard Deviation 3.1
|
2.8 ng/mL
Standard Deviation 3.5
|
5.7 ng/mL
Standard Deviation 3.8
|
17.3 ng/mL
Standard Deviation 27.2
|
16.7 ng/mL
Standard Deviation 15.1
|
17.2 ng/mL
Standard Deviation 23.6
|
33.8 ng/mL
Standard Deviation 28.6
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
Day 6
|
1.2 ng/mL
Standard Deviation 0.4
|
1.3 ng/mL
Standard Deviation 1.0
|
1.3 ng/mL
Standard Deviation 0.8
|
6.4 ng/mL
Standard Deviation 10.2
|
1.2 ng/mL
Standard Deviation 0.6
|
4.0 ng/mL
Standard Deviation 7.7
|
6.6 ng/mL
Standard Deviation 9.4
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
Day 8
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.1 ng/mL
Standard Deviation 0.4
|
—
|
|
Plasma Concentrations of Oxfendazole Sulfone
Day 15
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
1.0 ng/mL
Standard Deviation 0.0
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dosePopulation: All participants receiving oxfendazole are included in the analysis population.
The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Oxfendazole
|
9.1 hours
Standard Deviation 27.5
|
8.5 hours
Standard Deviation 25.3
|
10.3 hours
Standard Deviation 35.7
|
9.6 hours
Standard Deviation 34.2
|
10.0 hours
Standard Deviation 21.8
|
9.8 hours
Standard Deviation 33.7
|
11.0 hours
Standard Deviation 44.5
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dosePopulation: All participants receiving oxfendazole are included in the analysis population.
Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax) of Oxfendazole
|
2.0 hours
Interval 2.0 to 2.1
|
2.0 hours
Interval 1.0 to 6.0
|
2.0 hours
Interval 1.0 to 2.0
|
2.0 hours
Interval 1.0 to 4.0
|
2.0 hours
Interval 2.0 to 9.5
|
2.0 hours
Interval 1.9 to 6.0
|
2.0 hours
Interval 1.4 to 7.9
|
—
|
SECONDARY outcome
Timeframe: Day 1-Day 15Population: All participants receiving oxfendazole are included in the analysis population.
Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations \<LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Urine Concentrations of Oxfendazole Fenbendazole
0-4 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Urine Concentrations of Oxfendazole Fenbendazole
4-8 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Urine Concentrations of Oxfendazole Fenbendazole
8-12 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Urine Concentrations of Oxfendazole Fenbendazole
12-24 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
|
Urine Concentrations of Oxfendazole Fenbendazole
24-32 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0.03 ng/mL
Standard Deviation 0.07
|
—
|
|
Urine Concentrations of Oxfendazole Fenbendazole
48-60 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0.28 ng/mL
Standard Deviation 0.78
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Day 1-Day 15Population: All participants receiving oxfendazole are included in the analysis population.
Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations \<LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Outcome measures
| Measure |
0.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 Participants
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Urine Concentrations of Oxfendazole Sulfone
0-4 hours
|
9.1 ng/mL
Standard Deviation 16.8
|
4.1 ng/mL
Standard Deviation 11.6
|
19.9 ng/mL
Standard Deviation 25.7
|
45.6 ng/mL
Standard Deviation 37.0
|
46.4 ng/mL
Standard Deviation 20.9
|
68.0 ng/mL
Standard Deviation 21.2
|
64.5 ng/mL
Standard Deviation 44.5
|
—
|
|
Urine Concentrations of Oxfendazole Sulfone
4-8 hours
|
18.9 ng/mL
Standard Deviation 13.8
|
24.9 ng/mL
Standard Deviation 18.3
|
38.2 ng/mL
Standard Deviation 20.3
|
86.0 ng/mL
Standard Deviation 68.9
|
88.1 ng/mL
Standard Deviation 27.6
|
105.8 ng/mL
Standard Deviation 36.4
|
124.1 ng/mL
Standard Deviation 72.8
|
—
|
|
Urine Concentrations of Oxfendazole Sulfone
8-12 hours
|
34.1 ng/mL
Standard Deviation 50.3
|
26.5 ng/mL
Standard Deviation 22.9
|
30.3 ng/mL
Standard Deviation 14.7
|
76.0 ng/mL
Standard Deviation 60.1
|
92.3 ng/mL
Standard Deviation 33.3
|
99.7 ng/mL
Standard Deviation 40.8
|
92.9 ng/mL
Standard Deviation 39.7
|
—
|
|
Urine Concentrations of Oxfendazole Sulfone
12-24 hours
|
18.9 ng/mL
Standard Deviation 29.1
|
26.3 ng/mL
Standard Deviation 33.7
|
15.8 ng/mL
Standard Deviation 18.5
|
100.4 ng/mL
Standard Deviation 87.2
|
91.8 ng/mL
Standard Deviation 46.7
|
69.9 ng/mL
Standard Deviation 49.0
|
139.0 ng/mL
Standard Deviation 137.7
|
—
|
|
Urine Concentrations of Oxfendazole Sulfone
24-32 hours
|
0 ng/mL
Standard Deviation 0
|
0.9 ng/mL
Standard Deviation 2.6
|
1.2 ng/mL
Standard Deviation 3.4
|
3.2 ng/mL
Standard Deviation 4.9
|
7.5 ng/mL
Standard Deviation 9.1
|
18.2 ng/mL
Standard Deviation 32.4
|
26.1 ng/mL
Standard Deviation 32.4
|
—
|
|
Urine Concentrations of Oxfendazole Sulfone
48-60 hours
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0.8 ng/mL
Standard Deviation 1.6
|
0 ng/mL
Standard Deviation 0
|
7.3 ng/mL
Standard Deviation 9.7
|
5.3 ng/mL
Standard Deviation 7.3
|
—
|
Adverse Events
0.5 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
7.5 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
15 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
30 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
60 mg/kg Oxfendazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 0.5 mg/kg of oxfendazole.
|
1 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 1 mg/kg of oxfendazole
|
3 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 3 mg/kg of oxfendazole
|
7.5 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 7.5 mg/kg of oxfendazole
|
15 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 15 mg/kg of oxfendazole
|
30 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 30 mg/kg of oxfendazole
|
60 mg/kg Oxfendazole
n=8 participants at risk
Participants received a single oral dose 60 mg/kg of oxfendazole
|
Placebo
n=14 participants at risk
Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
25.0%
2/8 • Number of events 2 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Investigations
Electrocardiogram PR Prolongation
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
|
Skin and subcutaneous tissue disorders
Hand Dermatitis
|
12.5%
1/8 • Number of events 1 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/8 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
0.00%
0/14 • Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60