Trial Outcomes & Findings for Drug-Drug Interaction Study: ASP2151 and Bupropion (NCT NCT02369172)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Results posted on

2019-02-21

Participant Flow

Participants took part in the study at one investigative site in United Kingdom from 03-February 2015 to 17-April 2015

Participant milestones

Participant milestones
Measure	Bupropion + ASP2151 400 mg ASP2151 followed by 150 mg Bupropion Bupropion ASP2151
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug-Drug Interaction Study: ASP2151 and Bupropion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupropion + ASP2151 n=24 Participants 400 mg ASP2151 followed by 150 mg Bupropion Bupropion ASP2151
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.6 year STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	24 participants n=5 Participants

PRIMARY outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Peak Plasma Concentration (Cmax) of Bupropion	91.28 ng/mL Geometric Coefficient of Variation 27.2	76.94 ng/mL Geometric Coefficient of Variation 30.3	92.21 ng/mL Geometric Coefficient of Variation 28	95 ng/mL Geometric Coefficient of Variation 25.2	—	—	—	—	—	—

PRIMARY outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Bupropion	777.6 h*ng/mL Geometric Coefficient of Variation 30	653.7 h*ng/mL Geometric Coefficient of Variation 26.1	785.5 h*ng/mL Geometric Coefficient of Variation 31.1	841.4 h*ng/mL Geometric Coefficient of Variation 29	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 32 days after the last dose

Refer to the result of adverse event.

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Number of Participants With Serious and Non-Serious Adverse Events Non-serious adverse event	12 participants	—	—	—	—	—	—	—	—	—
Number of Participants With Serious and Non-Serious Adverse Events serious adverse event	0 participants	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Peak Plasma Concentration (Cmax) of Hydroxybupropion	295.4 ng/mL Geometric Coefficient of Variation 30.9	300.7 ng/mL Geometric Coefficient of Variation 32.6	300.6 ng/mL Geometric Coefficient of Variation 27.5	291.6 ng/mL Geometric Coefficient of Variation 31.2	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Time of Peak Concentration (Tmax) of Hydroxybupropion	8 h Interval 4.0 to 10.08	8 h Interval 5.0 to 24.0	8 h Interval 5.0 to 12.0	8 h Interval 3.0 to 12.02	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Hydroxybupropion	10524.7 h*ng/mL Geometric Coefficient of Variation 32.9	10160.7 h*ng/mL Geometric Coefficient of Variation 37.7	11135.4 h*ng/mL Geometric Coefficient of Variation 34.1	10963 h*ng/mL Geometric Coefficient of Variation 37.4	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Hydroxybupropion	11195.7 h*ng/mL Geometric Coefficient of Variation 33.7	10838.3 h*ng/mL Geometric Coefficient of Variation 38	12037.2 h*ng/mL Geometric Coefficient of Variation 36.1	11825.3 h*ng/mL Geometric Coefficient of Variation 38	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Half-life (t1/2) of Hydroxybupropion	21.38 h Geometric Coefficient of Variation 20.6	20.97 h Geometric Coefficient of Variation 20.3	23.07 h Geometric Coefficient of Variation 23.8	22.89 h Geometric Coefficient of Variation 16.8	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Days 6-14 and at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 n=24 Participants Day 10 pre-dose	Day 11 n=24 Participants Day 11 pre-dose	Day 12 n=24 Participants Day 12 pre-dose	Day 13 n=24 Participants Day 13 pre-dose	Day 14 n=24 Participants Day 14 pre-dose	Day 15 n=24 Participants Day 15 pre-dose
Trough Plasma Concentration (Ctrough) of ASP2151	0 ng/mL Standard Deviation 0	244.95 ng/mL Standard Deviation 104.63	245.83 ng/mL Standard Deviation 122.39	219.17 ng/mL Standard Deviation 105.83	185.31 ng/mL Standard Deviation 84.66	199.16 ng/mL Standard Deviation 105.72	197.05 ng/mL Standard Deviation 99.95	192.66 ng/mL Standard Deviation 102.29	188.46 ng/mL Standard Deviation 95.75	178.93 ng/mL Standard Deviation 87.78

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Peak Plasma Concentration (Cmax) of ASP2151	1409.8 ng/mL Geometric Coefficient of Variation 33.7	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Time of Peak Concentration (Tmax) of ASP2151	3 h Interval 1.0 to 5.0	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau) of ASP2151	14201.4 h*ng/mL Geometric Coefficient of Variation 33.5	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151	15968.1 h*ng/mL Geometric Coefficient of Variation 35.1	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Half-life (t1/2) of ASP2151	7.198 h Geometric Coefficient of Variation 16.7	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Apparent Volume of Distribution (Vd/F) of ASP2151	274 L Standard Deviation 97.85	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 150 mg bupropion with 400 mg ASP2151	Day 22 150 mg bupropion alone	Day 29 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Apparent Total Body Clearance (CL/F) of ASP2151	26.43 L/h Standard Deviation 8.65	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Time of Peak Concentration (Tmax) of Bupropion	3 h Interval 2.0 to 6.0	3 h Interval 1.0 to 5.98	3 h Interval 2.0 to 5.0	3 h Interval 1.0 to 5.0	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Area Under the Curve Over up to Last No-zero Value (AUC0-tn) of Bupropion	732.3 h*ng/mL Geometric Coefficient of Variation 29.9	608.9 h*ng/mL Geometric Coefficient of Variation 26.5	742.8 h*ng/mL Geometric Coefficient of Variation 31.8	794.2 h*ng/mL Geometric Coefficient of Variation 29.4	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Half-life (t1/2) of Bupropion	9.76 h Geometric Coefficient of Variation 47.7	8.16 h Geometric Coefficient of Variation 42.1	9.13 h Geometric Coefficient of Variation 37	10.92 h Geometric Coefficient of Variation 42.7	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Apparent Volume of Distribution (Vd/F) of Bupropion	2801.5 L Standard Deviation 723.1	2791.4 L Standard Deviation 747.05	2581.2 L Standard Deviation 588.69	2979.7 L Standard Deviation 1124.63	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29

Outcome measures

Outcome measures
Measure	Day 1 n=24 Participants 150 mg bupropion alone	Day 15 n=24 Participants 150 mg bupropion with 400 mg ASP2151	Day 22 n=24 Participants 150 mg bupropion alone	Day 29 n=24 Participants 150 mg bupropion alone	Day 10 Day 10 pre-dose	Day 11 Day 11 pre-dose	Day 12 Day 12 pre-dose	Day 13 Day 13 pre-dose	Day 14 Day 14 pre-dose	Day 15 Day 15 pre-dose
Apparent Total Body Clearance (CL/F) of Bupropion	200.64 L/h Standard Deviation 56.33	236.46 L/h Standard Deviation 57.2	199.59 L/h Standard Deviation 62.04	185.59 L/h Standard Deviation 57.71	—	—	—	—	—	—

Adverse Events

Bupropion

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ASP2151 After Bupropion

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Bupropion With ASP2151

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Maruho Co.,Ltd. Kyoto R&D Center

Clinical Development Dept.

Phone: +81-75-325-3255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bupropion n=24 participants at risk after dosing with bupropion on Day 1 and before the first dose of ASP2151 on Day 6.	ASP2151 After Bupropion n=24 participants at risk after the first dose of ASP2151 on Day 6, and before co-administration of bupropion and ASP2151 on Day 15.	Bupropion With ASP2151 n=24 participants at risk after co-administration of bupropion and ASP2151 on Day 15.	Total n=24 participants at risk
Nervous system disorders Headache	4.2% 1/24 • Up to 32 days after the last dose	8.3% 2/24 • Up to 32 days after the last dose	16.7% 4/24 • Up to 32 days after the last dose	25.0% 6/24 • Up to 32 days after the last dose
Nervous system disorders Neuralgia	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
General disorders Catheter site pain	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	8.3% 2/24 • Up to 32 days after the last dose
General disorders Catheter site haematoma	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
General disorders Catheter site phlebitis	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
General disorders Catheter site related reactions	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
General disorders Vessel puncture site pain	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Infections and infestations Rhinitis	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	8.3% 2/24 • Up to 32 days after the last dose	8.3% 2/24 • Up to 32 days after the last dose
Infections and infestations Nasopharyngitis	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Infections and infestations Otitis media	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Musculoskeletal and connective tissue disorders Back pain	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	8.3% 2/24 • Up to 32 days after the last dose
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Skin and subcutaneous tissue disorders Skin irritation	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Psychiatric disorders Anxiety	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	8.3% 2/24 • Up to 32 days after the last dose
Psychiatric disorders Insomnia	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Gastrointestinal disorders Abdominal	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Gastrointestinal disorders Concstipation	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/24 • Up to 32 days after the last dose	0.00% 0/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose	4.2% 1/24 • Up to 32 days after the last dose