Trial Outcomes & Findings for Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers (NCT NCT03301298)
NCT ID: NCT03301298
Last Updated: 2019-09-26
Results Overview
Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
8 days
Results posted on
2019-09-26
Participant Flow
Participant milestones
| Measure |
SXC-2023, 50 mg
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Unfed Conditions
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Unfed Conditions
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
|
Unfed Conditions
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fed Conditions
STARTED
|
0
|
0
|
0
|
0
|
5
|
0
|
2
|
|
Fed Conditions
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
0
|
2
|
|
Fed Conditions
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
SXC-2023, 50 mg
n=6 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
n=6 Participants
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
n=6 Participants
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
n=6 Participants
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
n=6 Participants
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
n=6 Participants
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo
n=12 Participants
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
48 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 11.26 • n=99 Participants
|
38 years
STANDARD_DEVIATION 13.93 • n=107 Participants
|
43.3 years
STANDARD_DEVIATION 9.35 • n=206 Participants
|
42.8 years
STANDARD_DEVIATION 14.41 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 9.09 • n=31 Participants
|
40 years
STANDARD_DEVIATION 5.73 • n=30 Participants
|
43.3 years
STANDARD_DEVIATION 9.43 • n=3 Participants
|
41.3 years
STANDARD_DEVIATION 10.15 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
23 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
37 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
11 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
43 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
6 participants
n=30 Participants
|
12 participants
n=3 Participants
|
48 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 8 daysTreatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.
Outcome measures
| Measure |
SXC-2023, 50 mg
n=6 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
n=6 Participants
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
n=6 Participants
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
n=6 Participants
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
n=6 Participants
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
n=6 Participants
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo Oral Capsule
n=12 Participants
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Experiencing TEAEs.
|
3 participants
|
0 participants
|
4 participants
|
1 participants
|
2 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Peak plasma concentration
Outcome measures
| Measure |
SXC-2023, 50 mg
n=6 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
n=6 Participants
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
n=6 Participants
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
n=6 Participants
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
n=6 Participants
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
n=6 Participants
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo Oral Capsule
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessments: Cmax
|
758.2 ng/mL
Geometric Coefficient of Variation 157.3
|
2181 ng/mL
Geometric Coefficient of Variation 58.3
|
5145 ng/mL
Geometric Coefficient of Variation 38.1
|
9005 ng/mL
Geometric Coefficient of Variation 60.4
|
25510 ng/mL
Geometric Coefficient of Variation 49.5
|
33700 ng/mL
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Population: Subject 1008 who received Treatment A in Cohort 1 did not have any measureable concentration of SXC-2023, NAC, or p-toluic acid and was excluded from the PK population.
Time to peak plasma concentration
Outcome measures
| Measure |
SXC-2023, 50 mg
n=5 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
n=6 Participants
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
n=6 Participants
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
n=6 Participants
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
n=6 Participants
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
n=6 Participants
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo Oral Capsule
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics Assessments: Tmax
|
3.111 hours
Interval 3.01 to 4.02
|
3.016 hours
Interval 2.01 to 6.0
|
4 hours
Interval 2.0 to 6.0
|
4 hours
Interval 2.0 to 4.01
|
2.501 hours
Interval 1.5 to 6.0
|
3.5 hours
Interval 2.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Area under the plasma concentration-time curve
Outcome measures
| Measure |
SXC-2023, 50 mg
n=6 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
n=6 Participants
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
n=6 Participants
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
n=6 Participants
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
n=6 Participants
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
n=6 Participants
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo Oral Capsule
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Assessments: AUC
|
3213 ng*hr/mL
Geometric Coefficient of Variation 154.1
|
9732 ng*hr/mL
Geometric Coefficient of Variation 73.9
|
25180 ng*hr/mL
Geometric Coefficient of Variation 43.2
|
57170 ng*hr/mL
Geometric Coefficient of Variation 54
|
139500 ng*hr/mL
Geometric Coefficient of Variation 28.6
|
239700 ng*hr/mL
Geometric Coefficient of Variation 29.8
|
—
|
SECONDARY outcome
Timeframe: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Population: Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate. Subject 5004 received fasted treatment but discontinued prior to fed treatment.
To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.
Outcome measures
| Measure |
SXC-2023, 50 mg
n=5 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo Oral Capsule
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Food Effect, AUC
|
158700 ng*hr/mL
Geometric Coefficient of Variation 31.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.Population: Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate. Subject 5004 received fasted treatment but discontinued prior to fed treatment.
To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.
Outcome measures
| Measure |
SXC-2023, 50 mg
n=5 Participants
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo Oral Capsule
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Food Effect, CMax
|
17160 ng/mL
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SXC-2023, 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SXC-2023, 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SXC-2023, 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SXC-2023, 400 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SXC-2023, 800 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SXC-2023, 1600 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SXC-2023, 50 mg
n=6 participants at risk
Single dose of 50 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 100 mg
n=6 participants at risk
Single dose of 100 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 200 mg
n=6 participants at risk
Single dose of 200mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 400 mg
n=6 participants at risk
Single dose of 400mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 800 mg
n=6 participants at risk
Single dose of 800mg, given orally in capsule form.
SXC-2023: Oral capsule
|
SXC-2023, 1600 mg
n=6 participants at risk
Single dose of 1600 mg, given orally in capsule form.
SXC-2023: Oral capsule
|
Placebo
n=12 participants at risk
Placebo comparator, given once orally in matching capsule form.
Placebo oral capsule: Placebo given as oral capsule.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
General disorders
Feeling hot
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
General disorders
Thirst
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Nervous system disorders
Dizziness postural
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 3 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Renal and urinary disorders
Micturation urgency
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
16.7%
1/6 • Number of events 2 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/6 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
0.00%
0/12 • Adverse events were collected from the time of subject informed consent through visit followup, approximately 7 days following study drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place