Trial Outcomes & Findings for A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood (NCT NCT06367153)
NCT ID: NCT06367153
Last Updated: 2026-05-22
Results Overview
This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.
Results posted on
2026-05-22
Participant Flow
This was a non-randomized, open-label, 2-period trial in healthy male and female participants in order to test the influence of multiple doses of BI 1569912 on the pharmacokinetics of repaglinide, midazolam, and bupropion (sensitive CYP2C8, CYP3A4 and CYP2B6 substrates).
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Reference Treatment (R), Then Test Treatment (T)
Reference (R) Treatment: On the morning of Day 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of Day 2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours.
Test Treatment (T): Healthy participants received in the morning, for 21 days (Day -14 to Day 7), the intended BI 1569912 daily dose, orally after an overnight fast of at least 10 hours. On the morning of Day 1, participants received after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of Day 2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912.
No washout period occurred between treatment periods.
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|---|---|
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Reference (R) treatment period
STARTED
|
18
|
|
Reference (R) treatment period
COMPLETED
|
17
|
|
Reference (R) treatment period
NOT COMPLETED
|
1
|
|
Test (T) treatment period
STARTED
|
17
|
|
Test (T) treatment period
COMPLETED
|
17
|
|
Test (T) treatment period
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Reference Treatment (R), Then Test Treatment (T)
Reference (R) Treatment: On the morning of Day 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of Day 2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours.
Test Treatment (T): Healthy participants received in the morning, for 21 days (Day -14 to Day 7), the intended BI 1569912 daily dose, orally after an overnight fast of at least 10 hours. On the morning of Day 1, participants received after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of Day 2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912.
No washout period occurred between treatment periods.
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|---|---|
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Reference (R) treatment period
Adverse Event
|
1
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Baseline Characteristics
A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood
Baseline characteristics by cohort
| Measure |
Reference Treatment (R), Then Test Treatment (T)
n=18 Participants
Reference (R) Treatment: On the morning of Day 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of Day 2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours.
Test Treatment (T): Healthy participants received in the morning, for 21 days (Day -14 to Day 7), the intended BI 1569912 daily dose, orally after an overnight fast of at least 10 hours. On the morning of Day 1, participants received after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of Day 2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912.
No washout period occurred between treatment periods.
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|---|---|
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Age, Continuous
|
35.4 Years
STANDARD_DEVIATION 9.8 • n=2 Participants
|
|
Sex: Female, Male
Female
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10 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=18 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
27332.41 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
21882.61 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
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|---|---|---|
|
Area Under Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
69127.73 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
57471.40 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured the area under the concentration-time curve of chiral form S-bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
312.11 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.11
|
302.02 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.11
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
2901.12 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
2665.85 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=18 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
25968.07 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
21329.40 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
This outcome measured maximum measured concentration of repaglinide in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=18 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
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Maximum Measured Concentration of Repaglinide in Plasma (Cmax)
|
19025.09 picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
16770.42 picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone or co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
65317.58 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
54970.22 hour*picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured maximum measured concentration of midazolam in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of Midazolam in Plasma (Cmax)
|
33379.74 picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
26797.94 picomole/liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured the area under the concentration-time curve of the chiral form S-bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
277.01 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
258.69 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured maximum measured concentration of the chiral form S-bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of S-bupropion in Plasma (Cmax)
|
23.19 nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
24.44 nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.13
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
2856.51 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
2622.90 hour*nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.Population: Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.
This outcome measured maximum measured concentration of total bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state. The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.
Outcome measures
| Measure |
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 Participants
Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period.
|
Midazolam 2 mg (R2)
n=17 Participants
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of Total Bupropion in Plasma (Cmax)
|
277.76 nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
261.76 nanomole/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
Adverse Events
Repaglinide 0.5 mg (R1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Midazolam 2 mg (R2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Bupropion 150 mg (R3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 1569912
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Repaglinide 0.5 mg + BI 1569912 (T1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam 2 mg + BI 1569912 (T2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Bupropion 150 mg + BI 1569912 (T3)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Repaglinide 0.5 mg (R1)
n=18 participants at risk
Healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally on the morning of Day 1 of the reference treatment period, after an overnight fast of at least 10 hours.
|
Midazolam 2 mg (R2)
n=17 participants at risk
Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours.
|
Bupropion 150 mg (R3)
n=17 participants at risk
Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours.
|
BI 1569912
n=17 participants at risk
Healthy participants received in the morning, for 14 days (Day -14 to Day -1 of the test treatment period), the intended dose of BI 1569912, orally after an overnight fast of at least 10 hours.
|
Repaglinide 0.5 mg + BI 1569912 (T1)
n=17 participants at risk
Healthy participants received after the administration of the intended dose of BI 1569912, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the test treatment period.
|
Midazolam 2 mg + BI 1569912 (T2)
n=17 participants at risk
Healthy participants received after the administration of the intended dose of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the test treatment period (T).
|
Bupropion 150 mg + BI 1569912 (T3)
n=17 participants at risk
Healthy participants received after the administration of the intended dose of BI 1569912, a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T).
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Application site rash
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Asthenia
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Early satiety
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
General disorders
Fatigue
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
17.6%
3/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
41.2%
7/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
29.4%
5/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
11.8%
2/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/18 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
0.00%
0/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
5.9%
1/17 • All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. Up to 15.5 days.
Treated set (TS): all participants who were treated with at least one dose of trial drug.
|
Additional Information
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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