Trial Outcomes & Findings for A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia (NCT NCT03627195)
NCT ID: NCT03627195
Last Updated: 2020-05-08
Results Overview
Number of subjects with any Adverse Events (AEs), serious adverse events (SAEs), and Adverse Events (AEs ) leading to study discontinuation
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 61
Results posted on
2020-05-08
Participant Flow
Participant milestones
| Measure |
Lurasidone 30 mg
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
Lurasidone injection suspension 450 mg
|
Placebo
Placebo Injection
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lurasidone 30 mg
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
Lurasidone injection suspension 450 mg
|
Placebo
Placebo Injection
|
|---|---|---|---|---|---|---|
|
Overall Study
OTHER (LACK OF EFFICACY)
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
Baseline characteristics by cohort
| Measure |
Lurasidone 30 mg
n=6 Participants
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
n=6 Participants
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
n=6 Participants
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
n=6 Participants
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
n=6 Participants
Lurasidone injection suspension 450 mg
|
Placebo
n=10 Participants
Placebo Injection
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
10 Participants
n=19 Participants
|
40 Participants
n=147 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Age, Continuous
|
43.7 Years
STANDARD_DEVIATION 13.29 • n=39 Participants
|
45 Years
STANDARD_DEVIATION 10.22 • n=41 Participants
|
52 Years
STANDARD_DEVIATION 4.47 • n=35 Participants
|
46.2 Years
STANDARD_DEVIATION 9.72 • n=31 Participants
|
52.8 Years
STANDARD_DEVIATION 11.81 • n=146 Participants
|
45.7 Years
STANDARD_DEVIATION 10.25 • n=19 Participants
|
47.4 Years
STANDARD_DEVIATION 10.23 • n=147 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
15 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
25 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
2 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
8 Participants
n=19 Participants
|
34 Participants
n=147 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
7 Participants
n=19 Participants
|
29 Participants
n=147 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
3 Participants
n=19 Participants
|
10 Participants
n=147 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
|
Height (cm)
|
170 cm
STANDARD_DEVIATION 8.83 • n=39 Participants
|
173.2 cm
STANDARD_DEVIATION 8.61 • n=41 Participants
|
174.3 cm
STANDARD_DEVIATION 10.39 • n=35 Participants
|
166.3 cm
STANDARD_DEVIATION 7.92 • n=31 Participants
|
174.2 cm
STANDARD_DEVIATION 7.25 • n=146 Participants
|
168.5 cm
STANDARD_DEVIATION 7.07 • n=19 Participants
|
170.8 cm
STANDARD_DEVIATION 8.29 • n=147 Participants
|
|
Weight (kg)
|
88.3 kg
STANDARD_DEVIATION 13.53 • n=39 Participants
|
80.3 kg
STANDARD_DEVIATION 10.86 • n=41 Participants
|
84.8 kg
STANDARD_DEVIATION 21.84 • n=35 Participants
|
82 kg
STANDARD_DEVIATION 16.55 • n=31 Participants
|
86.8 kg
STANDARD_DEVIATION 15.2 • n=146 Participants
|
86.7 kg
STANDARD_DEVIATION 15.07 • n=19 Participants
|
85 kg
STANDARD_DEVIATION 14.99 • n=147 Participants
|
|
BMI (kg/m^2)
|
30.88 kg/m^2
STANDARD_DEVIATION 6.444 • n=39 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 5.522 • n=41 Participants
|
27.68 kg/m^2
STANDARD_DEVIATION 5.975 • n=35 Participants
|
29.83 kg/m^2
STANDARD_DEVIATION 6.493 • n=31 Participants
|
28.77 kg/m^2
STANDARD_DEVIATION 5.125 • n=146 Participants
|
30.37 kg/m^2
STANDARD_DEVIATION 3.919 • n=19 Participants
|
29.23 kg/m^2
STANDARD_DEVIATION 5.295 • n=147 Participants
|
|
Baseline Positive and Negative Syndrome Scale (PANSS) Total Score
|
60.2 units on a scale
STANDARD_DEVIATION 7.76 • n=39 Participants
|
62 units on a scale
STANDARD_DEVIATION 8.25 • n=41 Participants
|
59.3 units on a scale
STANDARD_DEVIATION 7.94 • n=35 Participants
|
53.7 units on a scale
STANDARD_DEVIATION 7.55 • n=31 Participants
|
58.3 units on a scale
STANDARD_DEVIATION 6.8 • n=146 Participants
|
64.3 units on a scale
STANDARD_DEVIATION 7.56 • n=19 Participants
|
60.1 units on a scale
STANDARD_DEVIATION 7.93 • n=147 Participants
|
PRIMARY outcome
Timeframe: Day 61Number of subjects with any Adverse Events (AEs), serious adverse events (SAEs), and Adverse Events (AEs ) leading to study discontinuation
Outcome measures
| Measure |
Lurasidone 30 mg
n=6 Participants
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
n=6 Participants
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
n=6 Participants
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
n=6 Participants
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
n=6 Participants
Lurasidone injection suspension 450 mg
|
Placebo
n=10 Participants
Placebo Injection
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
Incidence of AEs
|
4 count of participants
|
4 count of participants
|
2 count of participants
|
4 count of participants
|
5 count of participants
|
5 count of participants
|
|
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
Incidence of SAEs
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
|
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs ) Leading to Study Discontinuation
Incidence of AEs leading to study discontinuation
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
0 count of participants
|
PRIMARY outcome
Timeframe: Day 61Population: Pharmacokinetic Population
The maximum Serum Concentration \[Cmax\] for lurasidone after lurasidone injectable suspension administration
Outcome measures
| Measure |
Lurasidone 30 mg
n=6 Participants
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
n=5 Participants
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
n=6 Participants
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
n=6 Participants
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
n=6 Participants
Lurasidone injection suspension 450 mg
|
Placebo
n=10 Participants
Placebo Injection
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration [Cmax] for Lurasidone After Lurasidone Injectable Suspension Administration
|
1.08 ng/mL
Geometric Coefficient of Variation 65.6
|
3.90 ng/mL
Geometric Coefficient of Variation 51.6
|
5.08 ng/mL
Geometric Coefficient of Variation 46.5
|
8.85 ng/mL
Geometric Coefficient of Variation 62.8
|
9.50 ng/mL
Geometric Coefficient of Variation 48.3
|
0 ng/mL
Geometric Coefficient of Variation 0
|
PRIMARY outcome
Timeframe: Day 61Population: Pharmacokinetic Population
The area Under the Curve from time 0 to time of last quantifiable concentration \[AUC0-last\] for lurasidone after lurasidone injectable suspension administration
Outcome measures
| Measure |
Lurasidone 30 mg
n=6 Participants
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
n=5 Participants
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
n=6 Participants
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
n=6 Participants
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
n=6 Participants
Lurasidone injection suspension 450 mg
|
Placebo
n=10 Participants
Placebo Injection
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Time of Last Quantifiable Concentration [AUC0-last] for Lurasidone After Lurasidone Injectable Suspension Administration
|
628 ng*h/mL
Geometric Coefficient of Variation 54.7
|
2000 ng*h/mL
Geometric Coefficient of Variation 6.6
|
3540 ng*h/mL
Geometric Coefficient of Variation 26.0
|
4910 ng*h/mL
Geometric Coefficient of Variation 47.9
|
7490 ng*h/mL
Geometric Coefficient of Variation 32.6
|
0 ng*h/mL
Geometric Coefficient of Variation 0
|
Adverse Events
Lurasidone 30 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lurasidone 75 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lurasidone 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lurasidone 300 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Lurasidone 450 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lurasidone 30 mg
n=6 participants at risk
Lurasidone injection suspension 30 mg
|
Lurasidone 75 mg
n=6 participants at risk
Lurasidone injection suspension 75 mg
|
Lurasidone 150 mg
n=6 participants at risk
Lurasidone injection suspension 150 mg
|
Lurasidone 300 mg
n=6 participants at risk
Lurasidone injection suspension 300 mg
|
Lurasidone 450 mg
n=6 participants at risk
Lurasidone injection suspension 450 mg
|
Placebo
n=10 participants at risk
Placebo Injection
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
General disorders
Feeling hot
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
General disorders
Injection site pain
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
33.3%
2/6 • Number of events 2 • 61 days
|
50.0%
3/6 • Number of events 3 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Immune system disorders
Food allergy
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 2 • 61 days
|
0.00%
0/10 • 61 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • 61 days
|
33.3%
2/6 • Number of events 2 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Investigations
Weight increased
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
33.3%
2/6 • Number of events 2 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
20.0%
2/10 • Number of events 2 • 61 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 2 • 61 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
66.7%
4/6 • Number of events 6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Nervous system disorders
Hypoaesthesia
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Nervous system disorders
Postural tremor
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
20.0%
2/10 • Number of events 2 • 61 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/10 • 61 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
10.0%
1/10 • Number of events 1 • 61 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 61 days
|
16.7%
1/6 • Number of events 1 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/6 • 61 days
|
0.00%
0/10 • 61 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER