Trial Outcomes & Findings for Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion (NCT NCT05976646)
NCT ID: NCT05976646
Last Updated: 2026-08-19
Results Overview
Measuring pulse is crucial for providing real-time, objective data. It acts as a baseline indicator to detect irregularities and monitor for stress and fatigue levels. The healthy resting heart rate (RHR) for most adults is 60-100 beats per minute (bpm). A lower rate usually indicates better cardiovascular fitness. A poor score is falling above the 60-100bpm range.
COMPLETED
PHASE1/PHASE2
18 participants
Baseline and Day 8 (PK testing visits)
2026-08-19
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Overall Study
STARTED
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6
|
12
|
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Overall Study
COMPLETED
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6
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12
|
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Overall Study
NOT COMPLETED
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0
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
Placebo: Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=12 Participants
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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Total
n=18 Participants
Total of all reporting groups
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|---|---|---|---|
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Region of Enrollment
United States
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6 participants
n=298 Participants
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12 participants
n=102 Participants
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18 participants
n=400 Participants
|
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Age, Continuous
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40.3 years
STANDARD_DEVIATION 11.0 • n=298 Participants
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44.0 years
STANDARD_DEVIATION 8.3 • n=102 Participants
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42.9 years
STANDARD_DEVIATION 9.2 • n=400 Participants
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|
Sex: Female, Male
Female
|
3 Participants
n=298 Participants
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4 Participants
n=102 Participants
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7 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
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3 Participants
n=298 Participants
|
8 Participants
n=102 Participants
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11 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Black/African American
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3 Participants
n=298 Participants
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5 Participants
n=102 Participants
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8 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=298 Participants
|
7 Participants
n=102 Participants
|
9 Participants
n=400 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=298 Participants
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0 Participants
n=102 Participants
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1 Participants
n=400 Participants
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PRIMARY outcome
Timeframe: Baseline and Day 8 (PK testing visits)Population: all participants who Started the study (i.e., 6 and 12 participants in each Arm/Group, respectively) were assessed at each time point reported in the data table.
Measuring pulse is crucial for providing real-time, objective data. It acts as a baseline indicator to detect irregularities and monitor for stress and fatigue levels. The healthy resting heart rate (RHR) for most adults is 60-100 beats per minute (bpm). A lower rate usually indicates better cardiovascular fitness. A poor score is falling above the 60-100bpm range.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=12 Participants
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Safety- as Measured by Average Heart Rate (Pulse) at Each Testing Visit
Baseline
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72.63 bpm
Standard Deviation 16.53
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72.81 bpm
Standard Deviation 7.90
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Safety- as Measured by Average Heart Rate (Pulse) at Each Testing Visit
Day 8
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67.53 bpm
Standard Deviation 9.04
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67.9 bpm
Standard Deviation 6.29
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PRIMARY outcome
Timeframe: Baseline and Day 8 (PK testing visits)Population: all participants who Started the study (i.e., 6 and 12 participants in each Arm/Group, respectively) were assessed at each time point reported in the data table.
Systolic blood pressure is the first (top/upper) number. It measures the pressure your blood is pushing against your artery walls when the heart beats. Diastolic blood pressure is the second (bottom/lower) number. It measures the pressure your blood is pushing against your artery walls while the heart muscle rests between beats. A good, healthy blood pressure for most adults is generally considered to be less than 120/80 mm Hg. It ensures participant safety by monitoring for extreme hypertension or hypotension, validating cardiovascular drug effects. Anything abovethe 130/80 mmHg is considered a high or bad reading. A high reading means that your heart is working too hard to pump blood and putting excessive strain on the arteries.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=12 Participants
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Safety- as Measured by Average Blood Pressure at Each Testing Visit
Diastolic Baseline
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73.10 mmHg
Standard Deviation 5.
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77.14 mmHg
Standard Deviation 8.15
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Safety- as Measured by Average Blood Pressure at Each Testing Visit
Diastolic Day 8
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75.33 mmHg
Standard Deviation 8.53
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75.57 mmHg
Standard Deviation 6.11
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Safety- as Measured by Average Blood Pressure at Each Testing Visit
Systolic Baseline
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125.93 mmHg
Standard Deviation 13.31
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128.71 mmHg
Standard Deviation 14.07
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Safety- as Measured by Average Blood Pressure at Each Testing Visit
Systolic Day 8
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122.47 mmHg
Standard Deviation 13.20
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125.38 mmHg
Standard Deviation 15.07
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PRIMARY outcome
Timeframe: Baseline and Day 8 (PK testing visits)Population: all participants who Started the study (i.e., 6 and 12 participants in each Arm/Group, respectively) were assessed at each time point reported in the data table.
Measuring pulse oximetry (SpO2) for research safety provides real-time, noninvasive monitoring of oxygen saturation, crucial for identifying "silent hypoxia," detecting respiratory decline from interventions, and ensuring participant safety during trials. The normal range is 95%-100%. Anything below the 95% is out of normal range and cause for concern.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=12 Participants
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Safety- as Measured by Average Pulse Oximetry at Each Testing Visit
Baseline
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98.07 percentage of SpO2
Standard Deviation 1.11
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97.75 percentage of SpO2
Standard Deviation 1.51
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Safety- as Measured by Average Pulse Oximetry at Each Testing Visit
Day 8
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98.87 percentage of SpO2
Standard Deviation .92
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97.22 percentage of SpO2
Standard Deviation 1.29
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PRIMARY outcome
Timeframe: Baseline and Day 8 (PK testing visits)Population: all participants who Started the study (i.e., 6 and 12 participants in each Arm/Group, respectively) were assessed at each time point reported in the data table.
A good, normal respiratory rate for research safety data in resting adults is 12 to 20 breaths per minute (bpm). Rates consistently under 12 or over 25 bpm are often flagged in clinical studies as potential safety concerns.
Outcome measures
| Measure |
Placebo
n=6 Participants
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=12 Participants
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Safety- as Measured by Average Respiratory Rate at Each Testing Visit
Baseline
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16.87 breaths/min
Standard Deviation 1.17
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16.33 breaths/min
Standard Deviation .63
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Safety- as Measured by Average Respiratory Rate at Each Testing Visit
Day 8
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16.67 breaths/min
Standard Deviation 1.09
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16.40 breaths/min
Standard Deviation .98
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PRIMARY outcome
Timeframe: Baseline to Week 2 follow-upPopulation: Values are number of events. Participants could report more than one adverse event. All participants who Started the study (i.e., 6 and 12 participants in each Arm/Group, respectively) were assessed at each time point reported in the data table.
Tracking adverse event (AE) rates in research is essential to ensure participant safety, determine the risk-benefit ratio of interventions, and maintain data integrity for regulatory approval. Analyzing these rates allows investigators to identify trends, detect unexpected risks early, and modify studies to prevent harm. .
Outcome measures
| Measure |
Placebo
n=12 Participants
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=6 Participants
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Safety- as Measured by Total Number of Adverse Events
HEENT
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4 Number of Adverse Events
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7 Number of Adverse Events
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Safety- as Measured by Total Number of Adverse Events
Cardiac
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1 Number of Adverse Events
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2 Number of Adverse Events
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Safety- as Measured by Total Number of Adverse Events
Gastrointestinal
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11 Number of Adverse Events
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9 Number of Adverse Events
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Safety- as Measured by Total Number of Adverse Events
Musculoskeletal and connective tissue
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2 Number of Adverse Events
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1 Number of Adverse Events
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Safety- as Measured by Total Number of Adverse Events
Nervous System
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11 Number of Adverse Events
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7 Number of Adverse Events
|
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Safety- as Measured by Total Number of Adverse Events
Psychiatric
|
5 Number of Adverse Events
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8 Number of Adverse Events
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Safety- as Measured by Total Number of Adverse Events
Reproductive and breast
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2 Number of Adverse Events
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1 Number of Adverse Events
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Safety- as Measured by Total Number of Adverse Events
skin and subcutaneous tisue
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0 Number of Adverse Events
|
1 Number of Adverse Events
|
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Safety- as Measured by Total Number of Adverse Events
Total AE's
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36 Number of Adverse Events
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36 Number of Adverse Events
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Adverse Events
Placebo
Auvelity
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo: Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Auvelity
n=12 participants at risk
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Auvelity: Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
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|---|---|---|
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Cardiac disorders
Cardiac
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33.3%
2/6 • Number of events 3 • From Baseline to end of study participation, approximately 3 weeks.
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8.3%
1/12 • Number of events 1 • From Baseline to end of study participation, approximately 3 weeks.
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Gastrointestinal disorders
Gastrointestinal
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66.7%
4/6 • Number of events 9 • From Baseline to end of study participation, approximately 3 weeks.
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33.3%
4/12 • Number of events 11 • From Baseline to end of study participation, approximately 3 weeks.
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Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue
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16.7%
1/6 • Number of events 1 • From Baseline to end of study participation, approximately 3 weeks.
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16.7%
2/12 • Number of events 2 • From Baseline to end of study participation, approximately 3 weeks.
|
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Nervous system disorders
Nervous System
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66.7%
4/6 • Number of events 7 • From Baseline to end of study participation, approximately 3 weeks.
|
58.3%
7/12 • Number of events 11 • From Baseline to end of study participation, approximately 3 weeks.
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Psychiatric disorders
Psychiatric
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66.7%
4/6 • Number of events 8 • From Baseline to end of study participation, approximately 3 weeks.
|
25.0%
3/12 • Number of events 5 • From Baseline to end of study participation, approximately 3 weeks.
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Reproductive system and breast disorders
Reproductive and breast
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16.7%
1/6 • Number of events 1 • From Baseline to end of study participation, approximately 3 weeks.
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8.3%
1/12 • Number of events 2 • From Baseline to end of study participation, approximately 3 weeks.
|
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Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue
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16.7%
1/6 • Number of events 1 • From Baseline to end of study participation, approximately 3 weeks.
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0.00%
0/12 • From Baseline to end of study participation, approximately 3 weeks.
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Ear and labyrinth disorders
HEENT
|
66.7%
4/6 • Number of events 7 • From Baseline to end of study participation, approximately 3 weeks.
|
16.7%
2/12 • Number of events 4 • From Baseline to end of study participation, approximately 3 weeks.
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Additional Information
Dr. F. Gerard Moeller
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place