Trial Outcomes & Findings for An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients (NCT NCT02649608)
NCT ID: NCT02649608
Last Updated: 2021-02-24
Results Overview
Number of patients with an adverse event
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Baseline to day 11
Results posted on
2021-02-24
Participant Flow
Groups are overlapping the cohorts
Participant milestones
| Measure |
Group 1
Patients received 0.2 mg, 0.4 mg, and 0.6 mg Lu AE04621 on Days 1, 2, and 3, respectively
|
Group 2
Patient received 0.2 mg, 0.4 mg, and 0.2 mg Lu AE04621 on Days 1, 2, and 3, respectively
|
Group 3
Patients received 0.4 mg, 0.6 mg, and 0.8 mg Lu AE04621 on Days 1, 2, and 3, respectively
|
Group 4
Patients received 0.2 mg, 0.4 mg, 0.6 mg, and 1.0 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
|
Group 5
Patients received 0.2 mg, 0.4 mg, 0.6 mg, and 1.2 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
|
Group 6
Patients received 0.2 mg, 0.4 mg, 0.4 mg, and 0.4 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
|
Group 7
Patient received 0.04 mg, 0.08 mg, 0.6 mg, and 0.6 mg Lu AE04621 on Days 1, 2, 3, and 4, respectively
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
3
|
3
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
3
|
3
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
Baseline characteristics by cohort
| Measure |
Lu AE04621
n=15 Participants
Patients having received 3 or 4 doses of Lu AE04621, ranging from 0.04 to 1.2 mg. Baseline measures are anlayzed on full patient group only.
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 11Population: Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of patients having received a particular dose.
Number of patients with an adverse event
Outcome measures
| Measure |
0.04 mg Lu AE04621
n=1 Participants
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
|
0.08 mg Lu AE04621
n=1 Participants
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
|
0.2 mg Lu AE04621
n=11 Participants
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
|
0.4 mg Lu AE04621
n=14 Participants
Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
|
0.6 mg Lu AE04621
n=12 Participants
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
|
0.8 mg Lu AE04621
n=3 Participants
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
|
1.0 mg Lu AE04621
n=3 Participants
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
|
1.2 mg Lu AE04621
n=3 Participants
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG)
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From dosing to up to 24 hours after dosingPopulation: The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. The results are reported for the dose groups with sufficient data to calculate the parameter (missing dose groups for AUC(0-24 hours) are: 0.04, 0.08, 0.8, 1.0 and 1.2 mg)
Outcome measures
| Measure |
0.04 mg Lu AE04621
n=9 Participants
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
|
0.08 mg Lu AE04621
n=11 Participants
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
|
0.2 mg Lu AE04621
n=9 Participants
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
|
0.4 mg Lu AE04621
Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
|
0.6 mg Lu AE04621
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
|
0.8 mg Lu AE04621
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
|
1.0 mg Lu AE04621
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
|
1.2 mg Lu AE04621
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621
|
212 pgxh/mL
Standard Deviation 268
|
292 pgxh/mL
Standard Deviation 219
|
309 pgxh/mL
Standard Deviation 276
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From dosing to up to 24 hours after dosingPopulation: Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data.
Outcome measures
| Measure |
0.04 mg Lu AE04621
n=1 Participants
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
|
0.08 mg Lu AE04621
n=1 Participants
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
|
0.2 mg Lu AE04621
n=11 Participants
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
|
0.4 mg Lu AE04621
n=17 Participants
Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
|
0.6 mg Lu AE04621
n=13 Participants
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
|
0.8 mg Lu AE04621
n=2 Participants
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
|
1.0 mg Lu AE04621
n=3 Participants
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
|
1.2 mg Lu AE04621
n=2 Participants
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for Lu AE04621
|
3.52 pg/mL
Standard Deviation 0
|
6.31 pg/mL
Standard Deviation 0
|
48.6 pg/mL
Standard Deviation 69.9
|
60.4 pg/mL
Standard Deviation 57.3
|
52.8 pg/mL
Standard Deviation 48.5
|
29.8 pg/mL
Standard Deviation 31.3
|
55.9 pg/mL
Standard Deviation 60.7
|
237 pg/mL
Standard Deviation 67.9
|
PRIMARY outcome
Timeframe: From dosing to up to 24 hours after dosingPopulation: The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. The results are reported for the dose groups with sufficient data to calculate the parameter (missing dose groups for t½ are: 0.04, 0.08, 0.8, 1.0 and 1.2 mg)
Outcome measures
| Measure |
0.04 mg Lu AE04621
n=9 Participants
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
|
0.08 mg Lu AE04621
n=10 Participants
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
|
0.2 mg Lu AE04621
n=9 Participants
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
|
0.4 mg Lu AE04621
Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
|
0.6 mg Lu AE04621
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
|
0.8 mg Lu AE04621
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
|
1.0 mg Lu AE04621
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
|
1.2 mg Lu AE04621
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Elimination Half-life of Lu AE04621 in Plasma (t½)
|
3.24 hour
Standard Deviation 2.43
|
5.00 hour
Standard Deviation 2.51
|
4.11 hour
Standard Deviation 2.01
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From dosing to 90 minutes after dosingPopulation: Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.
"ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.
Outcome measures
| Measure |
0.04 mg Lu AE04621
n=6 dosing occasion when patient turned ON
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
|
0.08 mg Lu AE04621
n=11 dosing occasion when patient turned ON
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
|
0.2 mg Lu AE04621
n=7 dosing occasion when patient turned ON
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
|
0.4 mg Lu AE04621
n=1 dosing occasion when patient turned ON
Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
|
0.6 mg Lu AE04621
n=2 dosing occasion when patient turned ON
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
|
0.8 mg Lu AE04621
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
|
1.0 mg Lu AE04621
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
|
1.2 mg Lu AE04621
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Onset of "ON" Time After Lu AE04621 Administration
|
35 minutes
Standard Deviation 20.4
|
41 minutes
Standard Deviation 28.6
|
39 minutes
Standard Deviation 22.7
|
17 minutes
Standard Deviation 0
|
20 minutes
Standard Deviation 17
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From dosing up to 24h post-dosePopulation: Each patient received 3 or 4 doses of Lu AE04621. The overall number analyzed in each group represents the number of dosing occasion at a particular dose when patients turned 'ON'. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.
"ON" state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to "ON" and "OFF" state. "OFF" state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621.
Outcome measures
| Measure |
0.04 mg Lu AE04621
n=6 Participants
Patients having received a dose of 0.04 mg, independent of which Cohort they belong to.
|
0.08 mg Lu AE04621
n=11 Participants
Patients having received a dose of 0.08 mg, independent of which Cohort they belong to.
|
0.2 mg Lu AE04621
n=7 Participants
Patients having received a dose of 0.2 mg, independent of which Cohort they belong to.
|
0.4 mg Lu AE04621
n=1 Participants
Patients having received a dose of 0.4 mg, independent of which Cohort they belong to
|
0.6 mg Lu AE04621
n=2 Participants
Patients having received a dose of 0.6 mg, independent of which Cohort they belong to.
|
0.8 mg Lu AE04621
Patients having received a dose of 0.8 mg, independent of which Cohort they belong to.
|
1.0 mg Lu AE04621
Patients having received a dose of 1.0 mg, independent of which Cohort they belong to.
|
1.2 mg Lu AE04621
Patients having received a dose of 1.2 mg, independent of which Cohort they belong to.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of "ON" Time
|
203 minutes
Standard Deviation 152.9
|
249 minutes
Standard Deviation 98.9
|
270 minutes
Standard Deviation 124.7
|
87 minutes
Standard Deviation 0
|
401 minutes
Standard Deviation 209.3
|
—
|
—
|
—
|
Adverse Events
0.04 mg Lu AE04621
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.08 mg Lu AE04621
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.2 mg Lu AE04621
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.4 mg Lu AE04621
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.6 mg Lu AE04621
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.8 mg Lu AE04621
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1 mg Lu AE04621
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1.2 mg Lu AE04621
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 |
0.04 mg Lu AE04621
n=1 participants at risk
|
0.08 mg Lu AE04621
n=1 participants at risk
|
0.2 mg Lu AE04621
n=11 participants at risk
|
0.4 mg Lu AE04621
n=14 participants at risk
|
0.6 mg Lu AE04621
n=12 participants at risk
|
0.8 mg Lu AE04621
n=3 participants at risk
|
1 mg Lu AE04621
n=3 participants at risk
|
1.2 mg Lu AE04621
n=3 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
21.4%
3/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
General disorders
Chills
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
14.3%
2/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Nervous system disorders
Sedation
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
9.1%
1/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Psychiatric disorders
Blunted affect
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
8.3%
1/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
33.3%
1/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
9.1%
1/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/1 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/11 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
7.1%
1/14 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/12 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
0.00%
0/3 • Baseline to day 11
Treatment-emergent adverse events are reported in this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place