Trial Outcomes & Findings for A Study in Healthy Men and Women to Test Which Effects Memantine and BI 425809 Have on Each Other (NCT NCT03988803)
NCT ID: NCT03988803
Last Updated: 2021-04-13
Results Overview
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Detailed time frame is described in the measure description section.
Results posted on
2021-04-13
Participant Flow
Non-randomised, single-arm, open-Label, three-period, one fixed sequence cross-over Study to investigate the effects of memantine in steady state on the pharmacokinetics of BI 425809 in steady state and vice versa in healthy male and female subjects.
All subjects were screened for eligibility to participate in trial. Subjects visited specialist site to ensure that they met all implemented inclusion criteria. Subjects meeting the exclusion criteria were excluded.
Participant milestones
| Measure |
BI 425809/Memantine/BI 425809+Memantine
Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2.
|
|---|---|
|
Screening
STARTED
|
16
|
|
Screening
COMPLETED
|
16
|
|
Screening
NOT COMPLETED
|
0
|
|
Period 1
STARTED
|
16
|
|
Period 1
COMPLETED
|
16
|
|
Period 1
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
16
|
|
Period 2
Treated
|
15
|
|
Period 2
Started Days 1 - 7: Multiple Doses of 5 mg Memantine qd
|
15
|
|
Period 2
Started Days 8 - 14: Multiple Doses of 10 mg Memantine qd
|
14
|
|
Period 2
Started Days 15 - 21: Multiple Doses of 15 mg Memantine qd
|
13
|
|
Period 2
Started Days 22 - 35: Multiple Doses of 20 mg Memantine qd
|
13
|
|
Period 2
COMPLETED
|
13
|
|
Period 2
NOT COMPLETED
|
3
|
|
Period 3
STARTED
|
13
|
|
Period 3
COMPLETED
|
13
|
|
Period 3
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
BI 425809/Memantine/BI 425809+Memantine
Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2.
|
|---|---|
|
Period 2
Prematurely discontinued from medication
|
2
|
|
Period 2
Adverse Event
|
1
|
Baseline Characteristics
A Study in Healthy Men and Women to Test Which Effects Memantine and BI 425809 Have on Each Other
Baseline characteristics by cohort
| Measure |
BI 425809/Memantine/BI 425809+Memantine
n=16 Participants
Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1. Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 mL of water after an overnight fast of at least 10 hours once daily. Dose was up-titrated starting with one tablet of 5 mg for days 1-7, for days 8 -14 one tablet of 10 mg, for days 15-21 one tablet of 15 mg, for days 22 - 28 one tablet of 20 mg, and from days 29 - 35 of period 2 one tablet of 20 mg for period 2. Treatment Period 3 (Test (T)): Oral administration of 25 mg BI 425809 in combination with oral administration one tablet of 20 mg memantine with 240 mL of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 3. Periods 1 and 2 with a washout period of at least 7 days. Period 3 followed directly after Period 2.
|
|---|---|
|
Age, Continuous
|
32.1 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 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: Detailed time frame is described in the measure description section.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as Primary and was not excluded due to protocol deviations relevant to the evaluation of PK or due to PK non-evaluability
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3.
Outcome measures
| Measure |
BI 425809
n=16 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
|
Memantine + BI 425809
n=13 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : BI 425809)
|
9029.04 nanomol * hours per liter
Standard Error 1.09
|
8559.78 nanomol * hours per liter
Standard Error 1.09
|
PRIMARY outcome
Timeframe: Detailed time frame can be found in the measure description.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as Primary and was not excluded due to protocol deviations relevant to the evaluation of PK or due to PK non-evaluability
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI 425809. Period 1 (BI 425809): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h (10 minutes (min) before the next dosing ) after first administration of BI 425809 on day 10 of Period 1. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 min before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after first administration of BI 425809 + Memantine on day 10 of Period 3.
Outcome measures
| Measure |
BI 425809
n=16 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
|
Memantine + BI 425809
n=13 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
|
|---|---|---|
|
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : BI 425809)
|
535.03 nanomol per liter
Standard Error 1.07
|
531.49 nanomol per liter
Standard Error 1.07
|
PRIMARY outcome
Timeframe: Detailed time frame is described in the measure description section.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as Primary and was not excluded due to protocol deviations relevant to the evaluation of PK or due to PK non-evaluability
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). Comparison of BI 425809 + Memantine versus BI 425809. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3.
Outcome measures
| Measure |
BI 425809
n=13 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
|
Memantine + BI 425809
n=13 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : Memantine)
|
1800.36 nanomol * hours per liter
Standard Error 1.09
|
1866.76 nanomol * hours per liter
Standard Error 1.09
|
PRIMARY outcome
Timeframe: Detailed time frame can be found in the measure description.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as Primary and was not excluded due to protocol deviations relevant to the evaluation of PK or due to PK non-evaluability
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss). Comparison of BI 425809 + Memantine versus BI Memantine. Treatment Period 2 (Memantine): Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12 h after administration of Memantine on day 35 of Period 2. Treatment Period 3 (Memantine + BI 425809) Measurements of steady state concentration where taken 10 minutes (min) before the next dosing of BI 425809 + Memantine and 30 min, 1h, 2h, 3h, 3h 30min, 4h, 4h 30min, 5h, 6h, 7h, 8h, 10h, 12h, 24h after administration of BI 425809 + Memantine on day 10 of Period 3.
Outcome measures
| Measure |
BI 425809
n=13 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
|
Memantine + BI 425809
n=13 Participants
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
|
|---|---|---|
|
Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (BI 425809 + Memantine : Memantine)
|
87.06 nanomol per liter
Standard Error 1.08
|
93.54 nanomol per liter
Standard Error 1.08
|
Adverse Events
BI 425809
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Memantine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Memantine + BI 425809
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 425809
n=16 participants at risk
Treatment period 1 (Reference 1 (R1)): Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily for days 1 - 10 of period 1.
|
Memantine
n=15 participants at risk
Treatment period 2 (Reference 2 (R2)): Oral administration of 1 film-coated tablet of Memantine alone with 240 milliliter (mL) of water after an overnight fast of at least 10 hours once daily.
Memantine was up-titrated starting with one tablet of 5 mg for days 1-7 of period 2, for days 8 -14 of period 2 one tablet of 10 mg Memantine daily, for days 15-21 one tablet of 15 mg Memantine daily, for days 22 - 28 of period 2 one tablet of 20 mg daily, and from days 29 - 35 of period 2 one tablet of 20 mg daily.
|
Memantine + BI 425809
n=15 participants at risk
Oral administration of 25 milligram (mg) BI 425809 (1 tablet of 25 mg) in combination with oral administration of 1 tablet of 20 mg Memantine with 240 milliliter (mL) of water after an overnight fast of at least 10 hours for days 1 - 10 of period 3.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
26.7%
4/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
13.3%
2/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
13.3%
2/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Nervous system disorders
Tension headache
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Nervous system disorders
Head discomfort
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
General disorders
Fatigue
|
31.2%
5/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
13.3%
2/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
13.3%
2/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
General disorders
Vessel puncture site reaction
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Psychiatric disorders
Change in sustained attention
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Psychiatric disorders
Listless
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
13.3%
2/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Eye disorders
Vision blurred
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Eye disorders
Photophobia
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Investigations
Eosinophil percentage increased
|
0.00%
0/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
6.7%
1/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
6.2%
1/16 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
0.00%
0/15 • Adverse events of BI 425809: up to 17 days. Adverse events of Memantine: up to 41 days. Adverse events of Memantine + BI 425809: up to 25 days. All-Cause Mortality was collected for up to 91 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug. The treated set was used for safety analyses
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER