Trial Outcomes & Findings for BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations (NCT NCT03608371)
NCT ID: NCT03608371
Last Updated: 2025-06-24
Results Overview
UPDRS = Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). The score ranges from 0-56.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
From pre-dose to 8 hours post-dose on Day 1
Results posted on
2025-06-24
Participant Flow
Participant milestones
| Measure |
BTRX-246040 Cohort 1
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
BTRX-246040 120 mg administered orally
|
Placebo
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BTRX-246040 Study in Participants With Parkinson's Disease With Motor Fluctuations
Baseline characteristics by cohort
| Measure |
BTRX-246040 Cohort 1
n=6 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=6 Participants
BTRX-246040 120 mg administered orally
|
Placebo
n=6 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
62.3 years
STANDARD_DEVIATION 7.09 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 8.07 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 4.76 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 5.35 • n=4 Participants
|
63.15 years
STANDARD_DEVIATION 6.32 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From pre-dose to 8 hours post-dose on Day 1Population: Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity.
UPDRS = Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). The score ranges from 0-56.
Outcome measures
| Measure |
BTRX-246040 Cohort 1
n=6 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=6 Participants
BTRX-246040 120 mg administered orally
|
Combined BTRX-246040
n=18 Participants
Combined BTRX-246040 groups
|
Placebo
n=6 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|---|
|
Maximal Change in UPDRS Part III From Predose to Postdose on Day 1
|
-22.0 score on a scale
Standard Deviation 7.01
|
-12.5 score on a scale
Standard Deviation 4.68
|
-11.2 score on a scale
Standard Deviation 3.92
|
-15.2 score on a scale
Standard Deviation 7.08
|
-17.0 score on a scale
Standard Deviation 12.07
|
SECONDARY outcome
Timeframe: From dose to 8 hours post-dose on Day 1Population: Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. 21 participants reached an ON status on Day 1; however, only 12 participants had a time recorded for when they reached OFF status on Day 1. Therefore, Duration of ON Time on Day 1 is only available for 12 participants.
ON is the typical functional state when patients are receiving medication and have a good response. OFF is the typical functional state when patients have a poor response in spite of taking medications.
Outcome measures
| Measure |
BTRX-246040 Cohort 1
n=3 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=4 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=1 Participants
BTRX-246040 120 mg administered orally
|
Combined BTRX-246040
n=8 Participants
Combined BTRX-246040 groups
|
Placebo
n=4 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|---|
|
Duration of ON Time on Day 1
|
2.983 hours
Standard Deviation 1.8144
|
3.750 hours
Standard Deviation 1.8484
|
4.000 hours
|
3.494 hours
Standard Deviation 1.6095
|
4.250 hours
Standard Deviation 1.5000
|
SECONDARY outcome
Timeframe: From dose to 8 hours post-dose on Day 1Population: Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity.
ON is the typical functional state when patients are receiving medication and have a good response. OFF is the typical functional state when patients have a poor response in spite of taking medications.
Outcome measures
| Measure |
BTRX-246040 Cohort 1
n=6 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=6 Participants
BTRX-246040 120 mg administered orally
|
Combined BTRX-246040
n=18 Participants
Combined BTRX-246040 groups
|
Placebo
n=6 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Turned ON on Day 1
|
6 Participants
|
6 Participants
|
4 Participants
|
16 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From dose to 8 hours post-dose on Day 1Population: Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity. 21 participants reached an ON status on Day 1.
ON is the typical functional state when patients are receiving medication and have a good response. OFF is the typical functional state when patients have a poor response in spite of taking medications.
Outcome measures
| Measure |
BTRX-246040 Cohort 1
n=6 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=4 Participants
BTRX-246040 120 mg administered orally
|
Combined BTRX-246040
n=16 Participants
Combined BTRX-246040 groups
|
Placebo
n=5 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|---|
|
Time to ON on Day 1
|
3.575 hours
Standard Deviation 2.7749
|
2.583 hours
Standard Deviation 2.7462
|
3.646 hours
Standard Deviation 2.7742
|
3.221 hours
Standard Deviation 2.6231
|
3.200 hours
Standard Deviation 2.8417
|
SECONDARY outcome
Timeframe: From pre-dose to 8 hours post-dose on Day 1Population: Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity.
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). UDPRS Part III was assessed pre-dose and every 30 minutes for 4 hours and then hourly for another 4 hours (i.e., 8 hours following study drug administration) on Day 1.
Outcome measures
| Measure |
BTRX-246040 Cohort 1
n=6 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=6 Participants
BTRX-246040 120 mg administered orally
|
Combined BTRX-246040
n=18 Participants
Combined BTRX-246040 groups
|
Placebo
n=6 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|---|
|
Area Under the Curve for UPDRS Part III During the 8 Hours of Assessment on Day 1
|
20224.50 score on a scale*minutes
Standard Deviation 2301.418
|
15464.33 score on a scale*minutes
Standard Deviation 5214.729
|
11682.42 score on a scale*minutes
Standard Deviation 2231.434
|
15790.42 score on a scale*minutes
Standard Deviation 4894.202
|
17547.08 score on a scale*minutes
Standard Deviation 3110.784
|
SECONDARY outcome
Timeframe: From pre-dose to 8 hours post-dose on Day 1Population: Modified Intent to Treat (mITT): all randomized participants who received at least 1 dose of the investigational product and had at least 1 post-baseline scoring of motor activity.
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). An additional single item to rate dyskinesia was added to the UDPRS and was rated from 0 (no dyskinesia) to 4 (severe dyskinesia: maximal amplitude and present during most of the examinations).
Outcome measures
| Measure |
BTRX-246040 Cohort 1
n=6 Participants
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 Participants
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=6 Participants
BTRX-246040 120 mg administered orally
|
Combined BTRX-246040
n=18 Participants
Combined BTRX-246040 groups
|
Placebo
n=6 Participants
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|---|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 30 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 60 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 90 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 120 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 150 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 180 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 210 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 240 minutes postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 5 hours postdose
|
0.3 score on a scale
Standard Deviation 0.82
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.1 score on a scale
Standard Deviation 0.47
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 6 hours postdose
|
0.3 score on a scale
Standard Deviation 0.82
|
0.0 score on a scale
Standard Deviation 0.00
|
0.3 score on a scale
Standard Deviation 0.52
|
0.2 score on a scale
Standard Deviation 0.55
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 7 hours postdose
|
0.3 score on a scale
Standard Deviation 0.82
|
0.0 score on a scale
Standard Deviation 0.00
|
0.2 score on a scale
Standard Deviation 0.41
|
0.2 score on a scale
Standard Deviation 0.51
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Pre-dose Dyskinesia Rating (From the UPDRS Part III Motor Response and Dyskinesia Assessment)
Postdose Day 1 Change, 8 hours postdose
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.00
|
0.2 score on a scale
Standard Deviation 0.41
|
0.1 score on a scale
Standard Deviation 0.24
|
0.0 score on a scale
Standard Deviation 0.00
|
Adverse Events
BTRX-246040 Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BTRX-246040 Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BTRX-246040 Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BTRX-246040 Cohort 1
n=6 participants at risk
BTRX-246040 40 mg administered orally
|
BTRX-246040 Cohort 2
n=6 participants at risk
BTRX-246040 80 mg administered orally
|
BTRX-246040 Cohort 3
n=6 participants at risk
BTRX-246040 120 mg administered orally
|
Placebo
n=6 participants at risk
Placebo administered orally at the same number of capsules as active drug in each Cohort
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Investigations
Blood urine present
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Investigations
Urine ketone body present
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
16.7%
1/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
0.00%
0/6 • Day 1 through Day 8 (+/- 1 day) or Early Termination visit, an average of 7 days.
All participants received study drugs and were monitored for AEs through Day 8 (+/- 1 day) or Early Termination Visit. The Investigators were responsible for following adverse event through to resolution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60