Trial Outcomes & Findings for A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil (NCT NCT03695094)
NCT ID: NCT03695094
Last Updated: 2020-06-04
Results Overview
The Cmax for Padsevonil in plasma was expressed in nanograms per milliliter (ng/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dose
Results posted on
2020-06-04
Participant Flow
The study started to enroll patients in September 2018 and concluded in May 2019.
The study included a Screening Period (Day -28 to Day -2), a Baseline Visit (Day -1), a Treatment Period (Day 1 to Day 12) and a Safety Follow-Up Period Day (13 to Day 20±1). Participant Flow refers to the Full Analysis Set.
Participant milestones
| Measure |
Group 1 (Inducers)
Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 milligrams per day (mg/day), which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
|
Group 2 (Neutral [Control])
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (Inducers)
Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 milligrams per day (mg/day), which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
|
Group 2 (Neutral [Control])
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
Baseline characteristics by cohort
| Measure |
Group 1 (Inducers)
n=16 Participants
Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 milligrams per day (mg/day), which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
|
Group 2 (Neutral [Control])
n=15 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state.
|
Total Title
n=31 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
33.6 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The Cmax for Padsevonil in plasma was expressed in nanograms per milliliter (ng/mL).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Maximum Observed Plasma Concentration (Cmax) of Padsevonil (PSL) During the Study
|
1210 ng/mL
Interval 1010.0 to 1450.0
|
1670 ng/mL
Interval 1390.0 to 2000.0
|
PRIMARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The tmax for Padsevonil in plasma was expressed in hours (hr).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Time to Reach Maximum Concentration (Tmax) for Padsevonil During the Study
|
1.500 hr
Interval 1.0 to 4.0
|
2.000 hr
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The AUCtau for Padsevonil in plasma was expressed in hours times nanograms per milliliter (hr\*ng/mL).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Area Under the Plasma Concentration Time Curve (AUCtau) Over a Dosing Interval for PSL
|
5301 hr*ng/mL
Interval 4350.0 to 6460.0
|
8339 hr*ng/mL
Interval 6850.0 to 10200.0
|
PRIMARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The CL/Fss for Padsevonil in plasma was expressed in liters per hour (L/hr). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Apparent Total Plasma Clearance at Steady-state (CL/Fss) for PSL During the Study
|
75.44 L/hr
Geometric Coefficient of Variation 34.8
|
47.94 L/hr
Geometric Coefficient of Variation 39.3
|
SECONDARY outcome
Timeframe: Trough plasma samples were taken prior to the morning dose of OXC on Day -1, Day 1 through Day 20 (+/-1)Population: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The trough plasma concentration of MHD with PSL was expressed in micrograms per milliliter (µg/mL). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 1
|
14.9 µg/mL
Geometric Coefficient of Variation 14.5
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 2
|
14.0 µg/mL
Geometric Coefficient of Variation 21.6
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 3
|
14.9 µg/mL
Geometric Coefficient of Variation 17.0
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 4
|
15.5 µg/mL
Geometric Coefficient of Variation 16.0
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 5
|
15.2 µg/mL
Geometric Coefficient of Variation 17.5
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 6
|
15.4 µg/mL
Geometric Coefficient of Variation 18.1
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 7
|
15.4 µg/mL
Geometric Coefficient of Variation 17.0
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 8
|
16.3 µg/mL
Geometric Coefficient of Variation 16.1
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 9
|
15.4 µg/mL
Geometric Coefficient of Variation 13.2
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 10
|
15.5 µg/mL
Geometric Coefficient of Variation 13.8
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 11
|
15.4 µg/mL
Geometric Coefficient of Variation 18.6
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 12
|
13.8 µg/mL
Geometric Coefficient of Variation 20.9
|
—
|
|
Trough Plasma Concentration of Mono Hydroxy Derivate (MHD) in the Inducers Group Before, During and After Dosing to Steady State With PSL
Day 13
|
11.3 µg/mL
Geometric Coefficient of Variation 46.4
|
—
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The Cmax for UCB1431322-000 in plasma was expressed in nanograms per milliliter (ng/mL). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Maximum Observed Plasma Concentration (Cmax) for UCB1431322-000 During the Study
|
1753 ng/mL
Geometric Coefficient of Variation 21.7
|
1700 ng/mL
Geometric Coefficient of Variation 29.4
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The tmax for UCB1431322-000 in plasma was expressed in hours (hr).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Time to Reach Maximum Concentration (Tmax) for UCB1431322-000 During the Study
|
3.500 hr
Interval 1.0 to 4.0
|
3.500 hr
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The AUCtau for UCB1431322-000 in plasma in was expressed in hours times nanograms per milliliter (hr\*ng/mL). Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1431322-000 During the Study
|
11720 hr*ng/mL
Geometric Coefficient of Variation 21.3
|
11200 hr*ng/mL
Geometric Coefficient of Variation 30.7
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
Metabolite-to-Parent Ratios were corrected for differences in molecular weight. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Ratio of PSL Metabolite UCB1431322-000 to PSL Based on the Area Under the Curve (AUCtau) During the Study
|
2.283 ratio
Geometric Coefficient of Variation 22.4
|
1.386 ratio
Geometric Coefficient of Variation 48.2
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The Cmax for UCB1447499-000 in plasma was expressed in ng/mL. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Maximum Observed Plasma Concentration (Cmax) for UCB1447499-000 During the Study
|
380.1 ng/mL
Geometric Coefficient of Variation 37.8
|
307.2 ng/mL
Geometric Coefficient of Variation 32.6
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The tmax for UCB1447499-000 in plasma was expressed in hr.
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Time to Reach Maximum Concentration (Tmax) for UCB1447499-000 During the Study
|
2.000 hr
Interval 1.0 to 4.0
|
2.000 hr
Interval 1.5 to 4.0
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The AUCtau for UCB1447499-000 in plasma was expressed in hr\*ng/mL. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Area Under the Curve (AUCtau) Over a Dosing Interval for UCB1447499-000 During the Study
|
1854 hr*ng/mL
Geometric Coefficient of Variation 29.0
|
1678 hr*ng/mL
Geometric Coefficient of Variation 28.2
|
SECONDARY outcome
Timeframe: Blood samples were taken on Day 1 through Day 12, prior to the morning dose of PSL, at Day 13 prior to unit discharge and at Day 8 at pre-defined time points up to 12 hours post-dosePopulation: The Pharmacokinetic Per-Protocol Set (PK-PPS) was a subset of the Full Analysis Set (FAS), consisting of study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
Metabolite-to-Parent Ratios were corrected for differences in molecular weight. Geometric Means and Coefficients of Variation (CVs) were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=14 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=14 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
The Ratio of PSL Metabolite UCB1447499-000 to PSL Based on the Area Under the Curve (AUCtau)
|
0.3492 ratio
Geometric Coefficient of Variation 32.8
|
0.2011 ratio
Geometric Coefficient of Variation 45.7
|
SECONDARY outcome
Timeframe: From screening (Day -28 to Day -2) up to end of study (EOS) visit day 20 (+/-1)Population: The Full Analysis Set (FAS) consisted of all study participants who signed the ICF and received at least 1 dose of IMP.
An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=16 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=15 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE) During the Study
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: From screening (Day -28 to Day -2) up to end of study (EOS) visit day 20 (+/-1)Population: The Full Analysis Set (FAS) consisted of all study participants who signed the ICF and received at least 1 dose of IMP.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in patient hospitalization or prolongation of existing hospitalization, was a congenital anomaly or birth defect, was an infection that requires treatment parenteral antibiotics or other important medical events which based on medical or scientific judgement could jeopardize the patients, or could require medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Group 1 (Inducers) (PK-PPS)
n=16 Participants
Participants were on stable therapy OXC, at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of LEV, LTG, or BRV. Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Pharmacokinetic Per-Protocol Set (PK-PPS).
|
Group 2 (Neutral [Control]) (PK-PPS)
n=15 Participants
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the PK-PPS.
|
|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Group 1 (Inducers) (FAS)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 2 (Neutral [Control]) (FAS)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Inducers) (FAS)
n=16 participants at risk
Participants were on stable therapy with oxcarbazepine (OXC), at least 1200 mg/day, which could be used as monotherapy or adjunctive to 1 or more of levetiracetam (LEV), lamotrigine (LTG), or brivaracetam (BRV). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the Full Analysis Set (FAS).
|
Group 2 (Neutral [Control]) (FAS)
n=15 participants at risk
Participants were on stable therapy with LTG (at least 150 mg/day monotherapy or adjunctive to LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up to 200 mg/day adjunctive to LTG). Padsevonil (PSL) was dosed to steady state (4.5 days) and the effect of background therapy on PSL pharmacokinetics (PK) was assessed at steady state. Participants formed the FAS.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Eye disorders
Diplopia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 3 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
26.7%
4/15 • Number of events 9 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 3 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
40.0%
6/15 • Number of events 18 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Feeling drunk
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
20.0%
3/15 • Number of events 4 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Feeling cold
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Chest pain
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Crying
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Feeling abnormal
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Feeling jittery
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Injection site haematoma
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
General disorders
Sluggishness
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Investigations
Blood calcium decreased
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Investigations
Blood sodium decreased
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Investigations
Blood calcium increased
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Investigations
Blood pressure increased
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Investigations
Blood sodium increased
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Investigations
Monocyte count increased
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 6 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Somnolence
|
75.0%
12/16 • Number of events 13 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
80.0%
12/15 • Number of events 53 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Dizziness
|
56.2%
9/16 • Number of events 18 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
66.7%
10/15 • Number of events 62 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Headache
|
50.0%
8/16 • Number of events 15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
60.0%
9/15 • Number of events 23 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Sudden onset of sleep
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
53.3%
8/15 • Number of events 36 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
26.7%
4/15 • Number of events 5 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
26.7%
4/15 • Number of events 8 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
6.2%
1/16 • Number of events 4 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
20.0%
3/15 • Number of events 3 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 3 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Anterograde amnesia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Dysgraphia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Slow response to stimuli
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Nervous system disorders
Stupor
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Agitation
|
12.5%
2/16 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
26.7%
4/15 • Number of events 8 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Disorientation
|
12.5%
2/16 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Irritability
|
6.2%
1/16 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 3 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 3 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/16 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
20.0%
3/15 • Number of events 10 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 2 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
0.00%
0/15 • Treatment Emergent Adverse events (TEAEs) were collected from the Baseline Visit (Day -1) until the Safety Follow-Up Period (Day 20±1).
Only TEAEs occurring above the reporting threshold of 5% of participants in any treatment group are included in this summary.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60