Trial Outcomes & Findings for A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules (NCT NCT04567524)
NCT ID: NCT04567524
Last Updated: 2023-02-08
Results Overview
Incidence of treatment emergent adverse events (TEAEs) reported as participants with at least one treatment emergent adverse event (TEAE).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
35 days
Results posted on
2023-02-08
Participant Flow
This study was conducted at 5 sites that randomized participants in the US. The study period was 13 August 2020 (first signed informed consent) to 22 December 2020 (last participant visit/observation)
A total of 34 participants were enrolled. Thirty-two participants completed the Run-in Period and were randomized, comprising the Safety Population; of these, 24 participants received LYN-005 (12 low dose; 12 high dose) and 8 participants received IR risperidone (4 low dose; 4 high dose).
Participant milestones
| Measure |
LYN-005 14mg
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Risperidone 2 mg
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
4
|
4
|
|
Overall Study
COMPLETED
|
9
|
11
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
LYN-005 14mg
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Risperidone 2 mg
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
Baseline Characteristics
A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules
Baseline characteristics by cohort
| Measure |
LYN-005 14 mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28 mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 6.24 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 7.46 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 7.85 • n=4 Participants
|
36.2 years
STANDARD_DEVIATION 7.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
29.57 kg/m^2
STANDARD_DEVIATION 4.695 • n=5 Participants
|
24.98 kg/m^2
STANDARD_DEVIATION 4.476 • n=7 Participants
|
26.48 kg/m^2
STANDARD_DEVIATION 2.680 • n=5 Participants
|
26.78 kg/m^2
STANDARD_DEVIATION 6.086 • n=4 Participants
|
27.11 kg/m^2
STANDARD_DEVIATION 4.835 • n=21 Participants
|
|
ESRS Total Score at Baseline
|
0.2 units on a scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
0.6 units on a scale
STANDARD_DEVIATION 2.02 • n=7 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
0.8 units on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
0.4 units on a scale
STANDARD_DEVIATION 1.36 • n=21 Participants
|
|
CGI-S Total Score at Baseline
|
2.9 units on a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.85 • n=7 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.50 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 0.50 • n=4 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.65 • n=21 Participants
|
PRIMARY outcome
Timeframe: 35 daysPopulation: Safety Population: All enrolled participants who were randomized to study drug (LYN-005 14 mg/28 mg or IR risperidone 2 mg/4 mg) and received at least 1 dose of randomized study drug. Participants were reported according to the treatment received. The Safety Population was the primary safety analysis population.
Incidence of treatment emergent adverse events (TEAEs) reported as participants with at least one treatment emergent adverse event (TEAE).
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=24 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=8 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Participants With at Least One Treatment Emergent Adverse Event (TEAE).
|
10 Number of Participants with TEAEs
|
8 Number of Participants with TEAEs
|
18 Number of Participants with TEAEs
|
1 Number of Participants with TEAEs
|
1 Number of Participants with TEAEs
|
2 Number of Participants with TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 35 daysPopulation: Safety Population: All enrolled participants who were randomized to study drug (LYN-005 14 mg/28 mg or IR risperidone 2 mg/4 mg) and received at least 1 dose of randomized study drug. Participants were reported according to the treatment received. The Safety Population was the primary safety analysis population.
Incidence of treatment emergent adverse events (TEAEs) reported as total number of TEAEs.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=24 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=8 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Number of Treatment Emergent Adverse Events (TEAEs).
|
15 Number of Experienced TEAEs
|
21 Number of Experienced TEAEs
|
36 Number of Experienced TEAEs
|
2 Number of Experienced TEAEs
|
2 Number of Experienced TEAEs
|
4 Number of Experienced TEAEs
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data.
Active moiety Cmax (risperidone and 9-hydroxyrisperidone combined) after repeat weekly doses of LYN-005 Extended Release (ER) capsules relative to Immediate Release (IR) risperidone tablets at 2 dose levels.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Active Moiety PK (Cmax)
|
31.0 ng/mL
Geometric Coefficient of Variation 37.5
|
20.0 ng/mL
Geometric Coefficient of Variation 56.7
|
18.6 ng/mL
Geometric Coefficient of Variation 42.9
|
24.8 ng/mL
Geometric Coefficient of Variation 38.3
|
30.3 ng/mL
Geometric Coefficient of Variation 17.5
|
31.2 ng/mL
Geometric Coefficient of Variation 68.7
|
24.6 ng/mL
Geometric Coefficient of Variation 405.7
|
31.2 ng/mL
Geometric Coefficient of Variation 32.1
|
30.4 ng/mL
Geometric Coefficient of Variation 102.7
|
54.1 ng/mL
Geometric Coefficient of Variation 19.3
|
46.3 ng/mL
Geometric Coefficient of Variation 23.8
|
48.8 ng/mL
Geometric Coefficient of Variation 40.9
|
PRIMARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data
Active moiety AUC (risperidone and 9-hydroxyrisperidone combined) after repeat weekly doses of LYN-005 ER capsules relative to IR risperidone tablets at 2 dose levels.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Active Moiety PK (AUC0-24, AUC0-168)
AUC0-24
|
377 h*ng/mL
Geometric Coefficient of Variation 44.0
|
361 h*ng/mL
Geometric Coefficient of Variation 49.0
|
371 h*ng/mL
Geometric Coefficient of Variation 47.4
|
301 h*ng/mL
Geometric Coefficient of Variation 23.1
|
326 h*ng/mL
Geometric Coefficient of Variation 19.1
|
359 h*ng/mL
Geometric Coefficient of Variation 32.6
|
472 h*ng/mL
Geometric Coefficient of Variation 137.7
|
575 h*ng/mL
Geometric Coefficient of Variation 39.3
|
568 h*ng/mL
Geometric Coefficient of Variation 104.3
|
732 h*ng/mL
Geometric Coefficient of Variation 46.3
|
753 h*ng/mL
Geometric Coefficient of Variation 44.9
|
687 h*ng/mL
Geometric Coefficient of Variation 36.9
|
|
Active Moiety PK (AUC0-24, AUC0-168)
AUC0-168
|
—
|
1820 h*ng/mL
Geometric Coefficient of Variation 52.1
|
2120 h*ng/mL
Geometric Coefficient of Variation 53.2
|
—
|
—
|
—
|
—
|
3350 h*ng/mL
Geometric Coefficient of Variation 42.3
|
2950 h*ng/mL
Geometric Coefficient of Variation 121.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data
Active Moiety Tmax (h) (risperidone and 9-hydroxyrisperidone combined) after repeat weekly doses of LYN-005 ER capsules relative to IR risperidone tablets at 2 dose levels.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Active Moiety Tmax
|
1.9 hours
Interval 0.0 to 4.0
|
23.7 hours
Interval 4.0 to 120.0
|
23.8 hours
Interval 0.0 to 72.0
|
3.0 hours
Interval 1.0 to 4.0
|
1.5 hours
Interval 1.0 to 2.0
|
3.0 hours
Interval 2.0 to 4.0
|
1.0 hours
Interval 0.6 to 7.9
|
24.1 hours
Interval 6.1 to 72.5
|
23.8 hours
Interval 0.0 to 169.0
|
2.1 hours
Interval 0.8 to 6.0
|
4.0 hours
Interval 1.1 to 6.1
|
2.0 hours
Interval 2.0 to 2.1
|
SECONDARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data
To characterize exposure (Cmax) of risperidone during the switch to LYN-005.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK of Risperidone (Cmax).
|
11.7 ng/mL
Geometric Coefficient of Variation 58.2
|
4.44 ng/mL
Geometric Coefficient of Variation 95.3
|
4.07 ng/mL
Geometric Coefficient of Variation 59.1
|
9.97 ng/mL
Geometric Coefficient of Variation 111.0
|
12.3 ng/mL
Geometric Coefficient of Variation 40.5
|
15.6 ng/mL
Geometric Coefficient of Variation 84.2
|
21.2 ng/mL
Geometric Coefficient of Variation 55.6
|
6.87 ng/mL
Geometric Coefficient of Variation 72.7
|
7.39 ng/mL
Geometric Coefficient of Variation 230.9
|
17.0 ng/mL
Geometric Coefficient of Variation 21.2
|
13.5 ng/mL
Geometric Coefficient of Variation 32.6
|
14.0 ng/mL
Geometric Coefficient of Variation 33.0
|
SECONDARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data
To characterize exposure (AUC0-24h, AUC0-168) of risperidone during the switch to LYN-005.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK of Risperidone (AUC0-24h, AUC0-168).
AUC0-24h
|
54.9 h*ng/mL
Geometric Coefficient of Variation 81.5
|
65.8 h*ng/mL
Geometric Coefficient of Variation 93.3
|
65.2 h*ng/mL
Geometric Coefficient of Variation 66.6
|
43.4 h*ng/mL
Geometric Coefficient of Variation 131.2
|
47.7 h*ng/mL
Geometric Coefficient of Variation 103.5
|
86.2 h*ng/mL
Geometric Coefficient of Variation 58.1
|
113 h*ng/mL
Geometric Coefficient of Variation 109.9
|
111 h*ng/mL
Geometric Coefficient of Variation 88.1
|
119 h*ng/mL
Geometric Coefficient of Variation 257.4
|
87.1 h*ng/mL
Geometric Coefficient of Variation 67.2
|
82.4 h*ng/mL
Geometric Coefficient of Variation 67.0
|
84.4 h*ng/mL
Geometric Coefficient of Variation 80.5
|
|
PK of Risperidone (AUC0-24h, AUC0-168).
AUC0-168
|
—
|
227 h*ng/mL
Geometric Coefficient of Variation 87.3
|
306 h*ng/mL
Geometric Coefficient of Variation 67.1
|
—
|
—
|
—
|
—
|
806 h*ng/mL
Geometric Coefficient of Variation 91.2
|
453 h*ng/mL
Geometric Coefficient of Variation 276.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data
To characterize exposure (Cmax) of 9-Hydroxyrisperidone during the switch to LYN-005.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK of 9-Hydroxyrisperidone (Cmax).
|
20.8 ng/mL
Geometric Coefficient of Variation 31.0
|
16.1 ng/mL
Geometric Coefficient of Variation 49.6
|
15.6 ng/mL
Geometric Coefficient of Variation 41.9
|
15.5 ng/mL
Geometric Coefficient of Variation 12.1
|
17.5 ng/mL
Geometric Coefficient of Variation 37.8
|
16.9 ng/mL
Geometric Coefficient of Variation 53.3
|
16.0 ng/mL
Geometric Coefficient of Variation 282.3
|
24.7 ng/mL
Geometric Coefficient of Variation 26.0
|
22.5 ng/mL
Geometric Coefficient of Variation 91.1
|
39.6 ng/mL
Geometric Coefficient of Variation 22.9
|
35.7 ng/mL
Geometric Coefficient of Variation 24.5
|
36.2 ng/mL
Geometric Coefficient of Variation 38.4
|
SECONDARY outcome
Timeframe: Reported data was obtained following multiple dose administration of 3 weekly doses [(IR, Day-1), (ER, Week 1), ER Week 3)] of 14 or 28 mg risperidone LYN-005 capsules to assess extended release PK.Population: All enrolled participants who received at least 1 dose of randomized study drug and had at least 1 post-dose quantifiable (or evaluable) PK concentration data
To characterize exposure (AUC0-24h, AUC0-168h) of 9-Hydroxyrisperidone during the switch to LYN-005.
Outcome measures
| Measure |
LYN-005 14mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28mg
n=12 Participants
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
Overall LYN-005
n=11 Participants
LYN-005 (14 mg) + LYN-005 (28 mg)
|
Risperidone 2 mg
n=4 Participants
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
Risperidone 4 mg
n=4 Participants
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
Overall Risperidone
n=4 Participants
Risperidone (2 mg) + Risperidone (4 mg)
|
LYN-005 28 mg (A)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (IR, Day -1)
|
LYN-005 28 mg (B)
n=12 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 1)
|
LYN-005 28 mg (C)
n=11 Participants
4 mg Risperidone to 28 mg LYN-005 (ER, Week 3)
|
Risperidone 4 mg (A)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day -1)
|
Risperidone 4 mg (B)
n=4 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 1)
|
Risperidone 4 mg (C)
n=3 Participants
4 mg Risperidone to 4 mg Risperidone (IR, Day 15)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK of 9-Hydroxyrisperidone (AUC0-24h, AUC0-168h).
AUC0-24h
|
315 h*ng/mL
Geometric Coefficient of Variation 39.7
|
268 h*ng/mL
Geometric Coefficient of Variation 38.2
|
302 h*ng/mL
Geometric Coefficient of Variation 47.0
|
243 h*ng/mL
Geometric Coefficient of Variation 11.2
|
262 h*ng/mL
Geometric Coefficient of Variation 20.8
|
265 h*ng/mL
Geometric Coefficient of Variation 26.6
|
268 h*ng/mL
Geometric Coefficient of Variation 272.6
|
441 h*ng/mL
Geometric Coefficient of Variation 33.6
|
523 h*ng/mL
Geometric Coefficient of Variation 177.9
|
641 h*ng/mL
Geometric Coefficient of Variation 43.5
|
665 h*ng/mL
Geometric Coefficient of Variation 42.9
|
645 h*ng/mL
Geometric Coefficient of Variation 45.5
|
|
PK of 9-Hydroxyrisperidone (AUC0-24h, AUC0-168h).
AUC0-168h
|
—
|
1530 h*ng/mL
Geometric Coefficient of Variation 51.7
|
1770 h*ng/mL
Geometric Coefficient of Variation 54.4
|
—
|
—
|
—
|
—
|
2720 h*ng/mL
Geometric Coefficient of Variation 35.9
|
2090 h*ng/mL
Geometric Coefficient of Variation 100.5
|
—
|
—
|
—
|
Adverse Events
LYN-005 14 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
LYN-005 28 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
IR Risperidone 2 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IR Risperidone 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LYN-005 14 mg
n=12 participants at risk
LYN-005: Size 00EL capsules containing LYN-005 stellate (14mg)
AND
IR risperidone matched placebo
|
LYN-005 28 mg
n=12 participants at risk
LYN-005: Size 00EL capsules containing LYN-005 stellate (28 mg)
AND
IR risperidone matched placebo
|
IR Risperidone 2 mg
n=4 participants at risk
Risperidone (2 mg)
AND
LYN-005-matched placebo
|
IR Risperidone 4 mg
n=4 participants at risk
Risperidone (4 mg)
AND
LYN-005-matched placebo.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
25.0%
3/12 • Number of events 3 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
25.0%
3/12 • Number of events 4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.7%
2/12 • Number of events 2 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
16.7%
2/12 • Number of events 2 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
16.7%
2/12 • Number of events 2 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
25.0%
1/4 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Investigations
Occult Blood Positive
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Investigations
Alanine Aminotransferase Increased
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
25.0%
1/4 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Investigations
Weight Increased
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
25.0%
1/4 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
16.7%
2/12 • Number of events 2 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Nervous system disorders
Akathisia
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
25.0%
1/4 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Endocrine disorders
Hyperprolactinaemia
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Infections and infestations
Diverticulitis
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/12 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
0.00%
0/4 • 35 days Double-blind Period consisted of the period between Day 1 to Day 35.
Safety Population consisted of all enrolled participants who were randomized to study drug (LYN-005 Low/High: 14 mg/28 mg or IR Risperidone Low/High: 2 mg/4 mg) and received at least 1 dose of randomized study drug. Double-blind Period consisted of the period between Day 1 to Day 35. If a participant had multiple AEs meeting a definition, the participant was presented only once in the respective participant count \[n (%)\].
|
Additional Information
Nayana Nagaraj, Senior Medical Director
Lyndra Therapeutics
Phone: 3023040091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place