Trial Outcomes & Findings for Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers (NCT NCT03035760)
NCT ID: NCT03035760
Last Updated: 2019-12-17
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
36 participants
Primary outcome timeframe
Day 1 through Day 10
Results posted on
2019-12-17
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 05JUN2017 and 10APR2018.
Participant milestones
| Measure |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
Arm 4A: 3 mg/kg Oxfendazole Fasted First, Then High Fat Meal
3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 and 3 mg/kg oxfendazole following a high fat meal on Day 8
|
Arm 4B: 3 mg/kg Oxfendazole High Fat Meal First, Then Fasted
3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 and 3 mg/kg oxfendazole following a fast on Day 8
|
|---|---|---|---|---|---|
|
First Intervention - 10/7 Days Follow-up
STARTED
|
8
|
8
|
8
|
6
|
6
|
|
First Intervention - 10/7 Days Follow-up
COMPLETED
|
8
|
8
|
8
|
6
|
6
|
|
First Intervention - 10/7 Days Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention - 7 Days Follow-up
STARTED
|
0
|
0
|
0
|
6
|
6
|
|
Second Intervention - 7 Days Follow-up
COMPLETED
|
0
|
0
|
0
|
6
|
6
|
|
Second Intervention - 7 Days Follow-up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
Arm 4A: 3 mg/kg Oxfendazole Fasted First, Then High Fat Meal
n=6 Participants
3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 and 3 mg/kg oxfendazole following a high fat meal on Day 8
|
Arm 4B: 3 mg/kg Oxfendazole High Fat Meal First, Then Fasted
n=6 Participants
3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 and 3 mg/kg oxfendazole following a fast on Day 8
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
36 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
27.1 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
30.1 years
STANDARD_DEVIATION 4.4 • n=27 Participants
|
27.7 years
STANDARD_DEVIATION 5.6 • n=483 Participants
|
32.2 years
STANDARD_DEVIATION 9.4 • n=36 Participants
|
29.2 years
STANDARD_DEVIATION 6.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
32 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
29 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
8 participants
n=27 Participants
|
6 participants
n=483 Participants
|
6 participants
n=36 Participants
|
36 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 10Population: 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3
|
3 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 14Population: 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=12 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=12 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5Population: All participants are included in the analysis population.
AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.
Outcome measures
| Measure |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Area Under the Concentration Time-curve for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3
Dose 1
|
30200 ng•hr/mL
Geometric Coefficient of Variation 66.7
|
52500 ng•hr/mL
Geometric Coefficient of Variation 73.9
|
71800 ng•hr/mL
Geometric Coefficient of Variation 50.7
|
|
Area Under the Concentration Time-curve for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3
Dose 5
|
38200 ng•hr/mL
Geometric Coefficient of Variation 33.1
|
65700 ng•hr/mL
Geometric Coefficient of Variation 34.5
|
69600 ng•hr/mL
Geometric Coefficient of Variation 28.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dosePopulation: All participants are included in the analysis population.
AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.
Outcome measures
| Measure |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=12 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4
Fed
|
58900 ng•hr/mL
Geometric Coefficient of Variation 25.5
|
—
|
—
|
|
Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4
Fasted
|
31600 ng•hr/mL
Geometric Coefficient of Variation 38.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5Population: All participants 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3
Dose 5
|
3500 ng/mL
Geometric Coefficient of Variation 16.3
|
5980 ng/mL
Geometric Coefficient of Variation 17.8
|
6000 ng/mL
Geometric Coefficient of Variation 28.4
|
|
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3
Dose 1
|
2960 ng/mL
Geometric Coefficient of Variation 42.7
|
4160 ng/mL
Geometric Coefficient of Variation 59.6
|
5990 ng/mL
Geometric Coefficient of Variation 53.1
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dosePopulation: All participants 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=12 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4
Fed
|
4500 ng/mL
Geometric Coefficient of Variation 19.5
|
—
|
—
|
|
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4
Fasted
|
3010 ng/mL
Geometric Coefficient of Variation 40.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5Population: All participants 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3
Dose 5
|
9.47 hours
Standard Deviation 2.34
|
11.00 hours
Standard Deviation 3.39
|
12.00 hours
Standard Deviation 2.65
|
|
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3
Dose 1
|
7.98 hours
Standard Deviation 1.47
|
8.54 hours
Standard Deviation 3.62
|
8.35 hours
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dosePopulation: All participants 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=12 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4
Fed
|
8.05 hours
Standard Deviation 0.776
|
—
|
—
|
|
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4
Fasted
|
7.65 hours
Standard Deviation 1.26
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5Population: All participants 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 Participants
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3
Dose 1
|
1.96 hours
Interval 1.83 to 8.55
|
2.02 hours
Interval 0.983 to 8.55
|
2.56 hours
Interval 0.983 to 8.92
|
|
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3
Dose 5
|
1.92 hours
Interval 1.02 to 3.0
|
2.02 hours
Interval 1.78 to 3.08
|
2.49 hours
Interval 0.917 to 3.02
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dosePopulation: All participants 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 |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=12 Participants
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4
Fed
|
8.9 hours
Interval 3.9 to 11.5
|
—
|
—
|
|
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4
Fasted
|
1.99 hours
Interval 1.0 to 2.98
|
—
|
—
|
Adverse Events
Arm 1: 3 mg/kg Oxfendazole for 5 Days
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3: 15 mg/kg Oxfendazole for 5 Days
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 4: 3 mg/kg Oxfendazole, Post Fast
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 4: 3 mg/kg Oxfendazole, Post Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: 3 mg/kg Oxfendazole for 5 Days
n=8 participants at risk
Participants received 3 mg/kg oxfendazole orally once daily for 5 days
|
Arm 2: 7.5 mg/kg Oxfendazole for 5 Days
n=8 participants at risk
Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days
|
Arm 3: 15 mg/kg Oxfendazole for 5 Days
n=8 participants at risk
Participants received 15 mg/kg oxfendazole orally once daily for 5 days
|
Arm 4: 3 mg/kg Oxfendazole, Post Fast
n=12 participants at risk
3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 or on Day 8
|
Arm 4: 3 mg/kg Oxfendazole, Post Fed
n=12 participants at risk
3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 or on Day 8
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
8.3%
1/12 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
8.3%
1/12 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
8.3%
1/12 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.5%
1/8 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngial Pain
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/8 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
0.00%
0/12 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).
|
8.3%
1/12 • Number of events 1 • AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 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