Trial Outcomes & Findings for A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route (NCT NCT02712554)
NCT ID: NCT02712554
Last Updated: 2019-10-14
Results Overview
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)
Results posted on
2019-10-14
Participant Flow
Total 12 subjects were enrolled and completed the Dose Selection phase. Subjects randomized to the Treatment phase were 40 and all of them received at least 1 dose of study drug, and 37 subjects completed the study.
Participant milestones
| Measure |
Part A (Dose Selection Phase): CL-108 or Placebo
Treatment AA: CL-108 15 mg/650 mg/25 mg tablet by mouth
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Treatment CC: CL-108 30 mg/1300 mg/50 mg tablet by mouth
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Treatment EE: Placebo 0 mg tablet by mouth
|
Part B (Treatment Phase): CL-108, M366 and Placebo
Treatment A (low-dose): CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Treatment B (high-dose): CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Treatment C (low-dose): M366 22.5 mg/975 mg tablet by mouth
Treatment D (high-dose): M366 37.5 mg/1625 mg tablet by mouth
Treatment E: Placebo 0 mg tablet by mouth
|
|---|---|---|
|
Part A: Dose Selection Phase
STARTED
|
12
|
0
|
|
Part A: Dose Selection Phase
COMPLETED
|
12
|
0
|
|
Part A: Dose Selection Phase
NOT COMPLETED
|
0
|
0
|
|
Part B: Qualification Phase
STARTED
|
0
|
61
|
|
Part B: Qualification Phase
COMPLETED
|
0
|
40
|
|
Part B: Qualification Phase
NOT COMPLETED
|
0
|
21
|
|
Part B: Treatment Phase
STARTED
|
0
|
40
|
|
Part B: Treatment Phase
COMPLETED
|
0
|
37
|
|
Part B: Treatment Phase
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Part A (Dose Selection Phase): CL-108 or Placebo
Treatment AA: CL-108 15 mg/650 mg/25 mg tablet by mouth
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Treatment CC: CL-108 30 mg/1300 mg/50 mg tablet by mouth
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Treatment EE: Placebo 0 mg tablet by mouth
|
Part B (Treatment Phase): CL-108, M366 and Placebo
Treatment A (low-dose): CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Treatment B (high-dose): CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Treatment C (low-dose): M366 22.5 mg/975 mg tablet by mouth
Treatment D (high-dose): M366 37.5 mg/1625 mg tablet by mouth
Treatment E: Placebo 0 mg tablet by mouth
|
|---|---|---|
|
Part B: Qualification Phase
Drug Discrimination Failure
|
0
|
13
|
|
Part B: Qualification Phase
Sponsor Decision
|
0
|
4
|
|
Part B: Qualification Phase
Withdrawal by Subject
|
0
|
3
|
|
Part B: Qualification Phase
Adverse Event
|
0
|
1
|
|
Part B: Treatment Phase
Adverse Event
|
0
|
1
|
|
Part B: Treatment Phase
Withdrawal by Subject
|
0
|
1
|
|
Part B: Treatment Phase
Other
|
0
|
1
|
Baseline Characteristics
A Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route
Baseline characteristics by cohort
| Measure |
Part A (Dose Selection Phase): CL-108 or Placebo
n=12 Participants
Treatment AA: CL-108 15 mg/650 mg/25 mg tablet by mouth
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Treatment CC: CL-108 30 mg/1300 mg/50 mg tablet by mouth
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Treatment EE: Placebo 0 mg tablet by mouth
|
Part B (Treatment Phase): CL-108, M366 and Placebo
n=40 Participants
Treatment A (low-dose): CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
Treatment B (high-dose): CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
Treatment C (low-dose): M366 22.5 mg/975 mg tablet by mouth
Treatment D (high-dose): M366 37.5 mg/1625 mg tablet by mouth
Treatment E: Placebo 0 mg tablet by mouth
|
Total
n=52 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
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
40 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)Population: Safety population. Parameters were not calculated for subjects who experienced emesis within the first 3 hours post-dose.
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=2 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=2 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=2 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=1 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=4 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
Emax
|
85.0 units on a scale
Standard Deviation 21.21
|
42.0 units on a scale
Standard Deviation 21.21
|
75.5 units on a scale
Standard Deviation 34.65
|
94.0 units on a scale
|
2.3 units on a scale
Standard Deviation 4.50
|
|
Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase
Emin
|
3.0 units on a scale
Standard Deviation 4.24
|
23.5 units on a scale
Standard Deviation 3.54
|
42.0 units on a scale
Standard Deviation 11.31
|
7.0 units on a scale
|
60.8 units on a scale
Standard Deviation 20.84
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)Population: Safety population. Parameters were not calculated for subjects who experienced emesis within the first 3 hours post-dose.
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=2 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=2 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=2 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=1 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=4 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase
|
86.0 units on a scale
Standard Deviation 19.80
|
48.5 units on a scale
Standard Deviation 26.16
|
75.0 units on a scale
Standard Deviation 35.36
|
94.0 units on a scale
|
4.3 units on a scale
Standard Deviation 5.68
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hoursPopulation: Intended to treat (ITT) population.
Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emax is the largest effect score between 0.5 to 24 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Emax of Drug Liking VAS in Treatment Phase
|
77.3 units on a scale
Standard Deviation 14.68
|
81.4 units on a scale
Standard Deviation 13.10
|
74.4 units on a scale
Standard Deviation 13.75
|
79.8 units on a scale
Standard Deviation 13.07
|
54.5 units on a scale
Standard Deviation 9.95
|
SECONDARY outcome
Timeframe: Up to visit 3 (Follow up)Population: Safety population.
AE=Adverse Event. SAE=Serious adverse event. TEAE=Treatment-emergent adverse event.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=12 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Number of Adverse Events in Dose Selection Phase
Total number of AEs
|
16 Event
|
—
|
—
|
—
|
—
|
|
Number of Adverse Events in Dose Selection Phase
Total Number of TEAEs
|
14 Event
|
—
|
—
|
—
|
—
|
|
Number of Adverse Events in Dose Selection Phase
Number of SAEs
|
0 Event
|
—
|
—
|
—
|
—
|
|
Number of Adverse Events in Dose Selection Phase
Number of AEs leading to Discontinuation
|
0 Event
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population.
Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emin is the smallest effect score between 0.5 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Balance of Effects: Emin of Drug Liking VAS in Treatment Phase
|
49.0 units on a scale
Standard Deviation 3.16
|
46.6 units on a scale
Standard Deviation 12.16
|
44.8 units on a scale
Standard Deviation 11.67
|
46.5 units on a scale
Standard Deviation 12.96
|
47.1 units on a scale
Standard Deviation 11.42
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase
|
12.071 units on a scale
Standard Deviation 10.4456
|
13.772 units on a scale
Standard Deviation 10.6773
|
9.773 units on a scale
Standard Deviation 12.4254
|
11.162 units on a scale
Standard Deviation 12.8093
|
1.183 units on a scale
Standard Deviation 5.0571
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population.
Overall drug liking VAS is the measure of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = 'strong disliking', 50 mm = 'neither like nor dislike', and 100 mm = 'strong liking'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
Emax
|
70.4 units on a scale
Standard Deviation 17.77
|
75.8 units on a scale
Standard Deviation 17.16
|
65.2 units on a scale
Standard Deviation 17.89
|
71.1 units on a scale
Standard Deviation 16.81
|
52.2 units on a scale
Standard Deviation 8.74
|
|
Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase
Emin
|
61.2 units on a scale
Standard Deviation 17.07
|
66.7 units on a scale
Standard Deviation 19.96
|
57.2 units on a scale
Standard Deviation 18.85
|
59.2 units on a scale
Standard Deviation 18.50
|
48.7 units on a scale
Standard Deviation 9.21
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population.
Take drug again VAS is the measure of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (0 mm = 'definitely not', 50 mm = 'do not care', and 100 mm = 'definitely so'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
Emax
|
74.6 units on a scale
Standard Deviation 18.98
|
75.2 units on a scale
Standard Deviation 18.49
|
68.9 units on a scale
Standard Deviation 19.89
|
71.3 units on a scale
Standard Deviation 20.51
|
51.1 units on a scale
Standard Deviation 12.45
|
|
Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase
Emin
|
66.4 units on a scale
Standard Deviation 19.85
|
69.3 units on a scale
Standard Deviation 21.07
|
60.9 units on a scale
Standard Deviation 21.19
|
61.9 units on a scale
Standard Deviation 20.68
|
47.5 units on a scale
Standard Deviation 12.04
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)Population: ITT population
High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score between 0 to 8 hours.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Positive Effects: Emax of High VAS in Treatment Phase
|
58.9 units on a scale
Standard Deviation 29.05
|
71.8 units on a scale
Standard Deviation 26.07
|
54.6 units on a scale
Standard Deviation 28.41
|
67.5 units on a scale
Standard Deviation 22.76
|
5.4 units on a scale
Standard Deviation 12.92
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)Population: ITT population
TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Positive Effects: TA_AUE of High VAS in Treatment Phase
|
1.055 units on a scale
Standard Deviation 2.8942
|
27.850 units on a scale
Standard Deviation 21.6226
|
36.363 units on a scale
Standard Deviation 21.0716
|
24.500 units on a scale
Standard Deviation 20.8024
|
32.050 units on a scale
Standard Deviation 20.7004
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
Good drug effects VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Positive Effects: Emax of Good Effects VAS in Treatment Phase
|
6.3 units on a scale
Standard Deviation 15.06
|
59.3 units on a scale
Standard Deviation 29.42
|
68.3 units on a scale
Standard Deviation 25.99
|
52.5 units on a scale
Standard Deviation 29.35
|
62.2 units on a scale
Standard Deviation 23.24
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase
|
28.108 units on a scale
Standard Deviation 22.0759
|
34.894 units on a scale
Standard Deviation 20.5885
|
25.541 units on a scale
Standard Deviation 23.1053
|
29.327 units on a scale
Standard Deviation 19.7001
|
1.140 units on a scale
Standard Deviation 2.9074
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hrs.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Negative Effects: Emax of Bad Effects VAS in Treatment Phase
|
14.8 units on a scale
Standard Deviation 21.89
|
30.1 units on a scale
Standard Deviation 29.35
|
20.1 units on a scale
Standard Deviation 20.61
|
36.1 units on a scale
Standard Deviation 30.39
|
2.4 units on a scale
Standard Deviation 9.68
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase
|
5.487 units on a scale
Standard Deviation 10.5253
|
12.535 units on a scale
Standard Deviation 16.0605
|
7.171 units on a scale
Standard Deviation 9.8243
|
13.830 units on a scale
Standard Deviation 14.9453
|
0.217 units on a scale
Standard Deviation 0.9084
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)Population: ITT population.
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. Emin is the smallest effect score between 0 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase
|
25.3 units on a scale
Standard Deviation 18.27
|
20.2 units on a scale
Standard Deviation 16.44
|
33.3 units on a scale
Standard Deviation 17.46
|
27.9 units on a scale
Standard Deviation 18.29
|
47.9 units on a scale
Standard Deviation 15.69
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)Population: ITT population.
Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase
|
-12.103 units on a scale
Standard Deviation 14.4192
|
-16.919 units on a scale
Standard Deviation 17.3774
|
-6.751 units on a scale
Standard Deviation 13.8670
|
-8.737 units on a scale
Standard Deviation 15.7482
|
-0.348 units on a scale
Standard Deviation 6.8048
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase
|
62.4 units on a scale
Standard Deviation 26.02
|
71.9 units on a scale
Standard Deviation 25.85
|
55.4 units on a scale
Standard Deviation 27.11
|
68.9 units on a scale
Standard Deviation 21.01
|
7.4 units on a scale
Standard Deviation 15.98
|
SECONDARY outcome
Timeframe: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hoursPopulation: ITT population
TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase
|
29.720 units on a scale
Standard Deviation 21.4816
|
38.504 units on a scale
Standard Deviation 20.2062
|
26.371 units on a scale
Standard Deviation 20.7356
|
34.030 units on a scale
Standard Deviation 19.3426
|
1.537 units on a scale
Standard Deviation 3.7125
|
SECONDARY outcome
Timeframe: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)Population: ITT population.
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
Baseline (Predose)
|
74.0 msec
Standard Deviation 103.15
|
51.9 msec
Standard Deviation 22.52
|
51.2 msec
Standard Deviation 16.83
|
56.8 msec
Standard Deviation 28.83
|
55.0 msec
Standard Deviation 19.48
|
|
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
1 hrs post-dose
|
-7.0 msec
Standard Deviation 104.21
|
9.8 msec
Standard Deviation 23.32
|
8.4 msec
Standard Deviation 24.48
|
11.1 msec
Standard Deviation 46.97
|
3.9 msec
Standard Deviation 34.65
|
|
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
2 hrs post-dose
|
21.7 msec
Standard Deviation 160.21
|
45.5 msec
Standard Deviation 81.23
|
24.8 msec
Standard Deviation 93.63
|
21.2 msec
Standard Deviation 55.12
|
8.8 msec
Standard Deviation 27.77
|
|
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
4 hrs post-dose
|
23.4 msec
Standard Deviation 155.96
|
38.3 msec
Standard Deviation 74.27
|
11.0 msec
Standard Deviation 32.97
|
7.9 msec
Standard Deviation 27.71
|
5.1 msec
Standard Deviation 20.10
|
|
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
8 hrs post-dose
|
-4.6 msec
Standard Deviation 104.99
|
29.0 msec
Standard Deviation 56.17
|
4.9 msec
Standard Deviation 30.03
|
9.0 msec
Standard Deviation 45.69
|
4.9 msec
Standard Deviation 30.57
|
|
Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase
24 hrs post-dose
|
-20.6 msec
Standard Deviation 103.86
|
4.9 msec
Standard Deviation 35.28
|
16.7 msec
Standard Deviation 70.86
|
6.3 msec
Standard Deviation 46.15
|
4.1 msec
Standard Deviation 29.93
|
SECONDARY outcome
Timeframe: 0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)Population: ITT population.
CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance. CRT also measures error scores and response accuracy. Any Errors is a combination of incorrect location errors, inaccurate response errors, no response errors, and premature errors.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
Baseline (Predose)
|
0.6 Error per msec
Standard Deviation 0.86
|
0.4 Error per msec
Standard Deviation 0.90
|
0.5 Error per msec
Standard Deviation 0.87
|
0.8 Error per msec
Standard Deviation 1.09
|
0.90 Error per msec
Standard Deviation 0.15
|
|
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
1 hrs post-dose
|
0.1 Error per msec
Standard Deviation 1.29
|
0.1 Error per msec
Standard Deviation 1.28
|
0.97 Error per msec
Standard Deviation 0.16
|
1.21 Error per msec
Standard Deviation 0.20
|
0.70 Error per msec
Standard Deviation 0.12
|
|
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
2 hrs post-dose
|
0.4 Error per msec
Standard Deviation 1.48
|
0.9 Error per msec
Standard Deviation 1.45
|
0.1 Error per msec
Standard Deviation 1.18
|
0.1 Error per msec
Standard Deviation 1.33
|
0.2 Error per msec
Standard Deviation 0.92
|
|
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
4 hrs post-dose
|
0.5 Error per msec
Standard Deviation 1.30
|
1.4 Error per msec
Standard Deviation 2.15
|
0.1 Error per msec
Standard Deviation 1.26
|
-0.1 Error per msec
Standard Deviation 1.36
|
0.1 Error per msec
Standard Deviation 1.10
|
|
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
8 hrs post-dose
|
0.2 Error per msec
Standard Deviation 1.95
|
0.9 Error per msec
Standard Deviation 2.11
|
0.1 Error per msec
Standard Deviation 0.94
|
0.0 Error per msec
Standard Deviation 1.21
|
0.1 Error per msec
Standard Deviation 0.19
|
|
Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase
24 hrs post-dose
|
0.3 Error per msec
Standard Deviation 1.49
|
-0.1 Error per msec
Standard Deviation 0.92
|
0.5 Error per msec
Standard Deviation 1.12
|
-0.1 Error per msec
Standard Deviation 0.91
|
0.1 Error per msec
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)Population: ITT population
Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. Pupil diameter was measured using electronic pupillometer. Measurements were collected under mesopic lighting conditions. For each subject, every effort was made to use the same eye for all assessments throughout the study. MPC is calculated as smallest observed pupil diameter - baseline pupil diameter.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Pupillometry: Maximum Pupil Constriction (MPC)
|
2.51 mm
Standard Deviation 0.852
|
3.15 mm
Standard Deviation 0.783
|
2.34 mm
Standard Deviation 0.852
|
2.75 mm
Standard Deviation 0.717
|
0.39 mm
Standard Deviation 0.537
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)Population: ITT population
TA\_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.
Outcome measures
| Measure |
Treatment AA: CL-108 15 mg/650 mg/25 mg
n=37 Participants
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Treatment BB: CL-108 22.5 mg/975 mg/37.5 mg
n=37 Participants
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment CC: CL-108 30 mg/1300 mg/50 mg
n=37 Participants
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Treatment DD: CL-108 37.5 mg/1625 mg/62.5 mg
n=37 Participants
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment EE: Placebo
n=37 Participants
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|
|
Pupillometry: TA_AUE of MPC in Treatment Phase
|
1.565 mm
Standard Deviation 0.7042
|
2.355 mm
Standard Deviation 0.7394
|
1.317 mm
Standard Deviation 0.7014
|
1.888 mm
Standard Deviation 0.5855
|
-0.153 mm
Standard Deviation 0.3308
|
Adverse Events
Dose Selection AA: CL-108 15 mg/650 mg/25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Selection BB: CL-108 22.5 mg/975 mg/37.5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Selection CC: CL-108 30 mg/1300 mg/50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Selection CC: CL-108 37.5 mg/1625 mg/62.5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Selection EE: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment AA: CL-108 22.5 mg/975 mg/37.5 mg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment BB: CL-108 37.5 mg/1625 mg/62.5 mg
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Treatment CC: M366 22.5 mg/975 mg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Treatment DD: M366 37.5 mg/1625 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Treatment EE: Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Selection AA: CL-108 15 mg/650 mg/25 mg
n=2 participants at risk
CL-108 15 mg/650 mg/25 mg tablet by mouth
|
Dose Selection BB: CL-108 22.5 mg/975 mg/37.5 mg
n=2 participants at risk
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Dose Selection CC: CL-108 30 mg/1300 mg/50 mg
n=2 participants at risk
CL-108 30 mg/1300 mg/50 mg tablet by mouth
|
Dose Selection CC: CL-108 37.5 mg/1625 mg/62.5 mg
n=2 participants at risk
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Dose Selection EE: Placebo
n=4 participants at risk
Placebo 0 mg tablet by mouth
|
Treatment AA: CL-108 22.5 mg/975 mg/37.5 mg
n=40 participants at risk
CL-108 22.5 mg/975 mg/37.5 mg tablet by mouth
|
Treatment BB: CL-108 37.5 mg/1625 mg/62.5 mg
n=39 participants at risk
CL-108 37.5 mg/1625 mg/62.5 mg tablet by mouth
|
Treatment CC: M366 22.5 mg/975 mg
n=38 participants at risk
M366 22.5 mg/975 mg tablet by mouth
|
Treatment DD: M366 37.5 mg/1625 mg
n=39 participants at risk
M366 37.5 mg/1625 mg tablet by mouth
|
Treatment EE: Placebo
n=39 participants at risk
Placebo 0 mg tablet by mouth
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
10.0%
4/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
10.5%
4/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
10.3%
4/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
32.5%
13/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
59.0%
23/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
36.8%
14/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
43.6%
17/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
25.0%
10/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
33.3%
13/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
26.3%
10/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
23.1%
9/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
12.8%
5/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.3%
2/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.3%
2/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
100.0%
2/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
100.0%
2/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
17.5%
7/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
28.2%
11/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
10.5%
4/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
23.1%
9/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.5%
3/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
12.8%
5/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
15.8%
6/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
17.9%
7/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.0%
2/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.5%
3/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.3%
2/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
12.8%
5/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
100.0%
2/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.9%
3/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
17.9%
7/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.3%
2/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
General disorders
Feeling Hot
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.0%
2/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
7.7%
3/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.3%
2/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
General disorders
Feeling of Relaxation
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.0%
2/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.5%
1/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.3%
2/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.0%
2/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
2.6%
1/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
5.1%
2/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
50.0%
1/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/2 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/4 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/40 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/38 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
0.00%
0/39 • Up to visit 3 (Follow up) for Dose Selection phase and Up to Day 24 (Follow up) for Treatment phase
Total 12 subjects in Dose Selection and 40 subjects in Treatment Phase are enrolled and received at least 1 dose of study drug and were included in the Safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place