Trial Outcomes & Findings for A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood (NCT NCT04899674)
NCT ID: NCT04899674
Last Updated: 2025-02-24
Results Overview
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. Time Frame: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))". Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).
Results posted on
2025-02-24
Participant Flow
This was a phase I, open-label, two-period fixed sequence trial to evaluate the effect of multiple doses of BI 1358894 on the pharmacokinetics of bupropion in healthy volunteers.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Bupropion Alone (Reference (R)) Then BI 1358894 + Bupropion (Test (T))
Reference (R): Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
Test (T): From Day -14 to Day 5 of Visit 3 (Period: Test) participants were administered orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On the 15th day of BI 1358894 administration (i.e. Day 1 of Visit 3 (Period: Test)) a single dose of 150 mg of bupropion was co-administered.
The single-dose administrations of bupropion in Periods Reference and Test were to be separated by an interval of 21 days.
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|---|---|
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Reference
STARTED
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18
|
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Reference
COMPLETED
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18
|
|
Reference
NOT COMPLETED
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0
|
|
Test
STARTED
|
18
|
|
Test
Treated With BI 1358894
|
18
|
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Test
Treated With BI 1358894I and Bupropion
|
17
|
|
Test
COMPLETED
|
17
|
|
Test
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Bupropion Alone (Reference (R)) Then BI 1358894 + Bupropion (Test (T))
Reference (R): Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
Test (T): From Day -14 to Day 5 of Visit 3 (Period: Test) participants were administered orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On the 15th day of BI 1358894 administration (i.e. Day 1 of Visit 3 (Period: Test)) a single dose of 150 mg of bupropion was co-administered.
The single-dose administrations of bupropion in Periods Reference and Test were to be separated by an interval of 21 days.
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|---|---|
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Test
Adverse Event
|
1
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Baseline Characteristics
A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood
Baseline characteristics by cohort
| Measure |
Bupropion Alone (Reference (R)) Then BI 1358894 + Bupropion (Test (T))
n=18 Participants
Reference (R): Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
Test (T): From Day -14 to Day 5 of Visit 3 (Period: Test) participants were administered orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On the 15th day of BI 1358894 administration (i.e. Day 1 of Visit 3 (Period: Test)) a single dose of 150 mg of bupropion was co-administered.
The single-dose administrations of bupropion in Periods Reference and Test were to be separated by an interval of 21 days.
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|---|---|
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Age, Continuous
|
38.7 Years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 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.
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented. Time Frame: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))". Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Outcome measures
| Measure |
Bupropion Alone (Reference (R))
n=16 Participants
Reference (R): Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
|
BI 1358894 + Bupropion (Test (T))
n=14 Participants
Test (T): Participants were administered from Day -14 to Day 5 of Visit 3 (Period: Test) orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On the 15th day of BI 1358894 administration (i.e. Day 1 of Visit 3 (Period: Test)) a single dose of 150 mg of bupropion was co-administered.
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|---|---|---|
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Area Under the Concentration-time Curve of Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
2953 hours * nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.102.
|
2795 hours * nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.104.
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PRIMARY outcome
Timeframe: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 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.
Maximum measured concentration of bupropion in plasma (Cmax) is presented. Timeframe: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))". Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Outcome measures
| Measure |
Bupropion Alone (Reference (R))
n=16 Participants
Reference (R): Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
|
BI 1358894 + Bupropion (Test (T))
n=14 Participants
Test (T): Participants were administered from Day -14 to Day 5 of Visit 3 (Period: Test) orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On the 15th day of BI 1358894 administration (i.e. Day 1 of Visit 3 (Period: Test)) a single dose of 150 mg of bupropion was co-administered.
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|---|---|---|
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Maximum Measured Concentration of Bupropion in Plasma (Cmax)
|
262 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.089.
|
237 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.096.
|
SECONDARY outcome
Timeframe: Up to 120 hours (h) after administration of bupropion (for detailed timeframe please see description).Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 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.
Area under the concentration-time curve of bupropion in plasma over the time interval from 0 to infinity (AUC0-∞) is presented. Time Frame: Within 3 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "bupropion alone (Reference (R))". Within 0.5 hours (h) before and 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 24 h, 48 h, 72 h, 96 h, 120 h after bupropion administration for the arm "BI 1358894 + bupropion (Test (T))".
Outcome measures
| Measure |
Bupropion Alone (Reference (R))
n=16 Participants
Reference (R): Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
|
BI 1358894 + Bupropion (Test (T))
n=14 Participants
Test (T): Participants were administered from Day -14 to Day 5 of Visit 3 (Period: Test) orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On the 15th day of BI 1358894 administration (i.e. Day 1 of Visit 3 (Period: Test)) a single dose of 150 mg of bupropion was co-administered.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Bupropion in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
|
3003 hours * nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.101.
|
2855 hours * nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.103.
|
Adverse Events
Bupropion
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 1358894
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 1358894 + Bupropion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion
n=18 participants at risk
Participants were administered on Day 1 of Visit 2 (Period: Reference) orally a single dose of 150 milligram (mg) of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 milliliter (mL) of water.
|
BI 1358894
n=18 participants at risk
Participants were administered from Day -14 to Day 5 (included) of Visit 3 (Period: Test) orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water.
|
BI 1358894 + Bupropion
n=17 participants at risk
Participants were administered from Day 1 to Day 5 of Visit 3 (Period: Test) orally once daily 2 film coated tablets of 50 mg of BI 1358894 (total dosage 100 mg/day) under fed conditions with 240 mL of water. On Day 1 participants were co-administered a single dose of 150 mg of bupropion sustained release (SR) tablet (Elontril®) under fed conditions with 240 mL of water.
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|---|---|---|---|
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Nervous system disorders
Headache
|
11.1%
2/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
44.4%
8/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
17.6%
3/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
27.8%
5/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
11.1%
2/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
General disorders
Fatigue
|
16.7%
3/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Investigations
Body temperature increased
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
5.6%
1/18 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
0.00%
0/17 • Bupropion (BP): From administration (ad.) of BP+5 days of residual effect period (REP), up to 5 days(d). BI 1358894 + Bupropion: From ad. of BP on Day 1 of Visit 3 + 5 days of REP, up to 5 d. "BI 1358894 (BI) alone: From ad. of BI until ad. of BP or until last ad. prior to BP ad. + 14 d" "BI alone (continued): and from ad. of BP + 5 d of REP until last ad. of BI + 14 d of REP, up to 28d.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
|
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