Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1 (NCT NCT03959189)
NCT ID: NCT03959189
Last Updated: 2021-06-23
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Adverse Events were collected from screening to the End of Study Visit, up to 57 days
Results posted on
2021-06-23
Participant Flow
Between June 2019 and March 2020, 12 patients were enrolled and treated with ERX-963 at three sites in the United States (Stanford University Neurosciences Health Center, University of Iowa Hospitals and Clinics, and Sleep Specialists of South Florida).
Participant milestones
| Measure |
Cohort 1: 1 mg ERX-963
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Baseline characteristics by cohort
| Measure |
Cohort 1: 1 mg ERX-963
n=7 Participants
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963
n=5 Participants
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
n=93 Participants
|
44.0 years
n=4 Participants
|
51.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
5 participants
n=4 Participants
|
12 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Adverse Events were collected from screening to the End of Study Visit, up to 57 daysPopulation: The safety population is defined as all participants who sign the study-specific informed consent documents and received at least 1 dose of ERX-963 or placebo.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
Outcome measures
| Measure |
Cohort 1: 1 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: Placebo Period
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963 Period
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
|---|---|---|---|---|
|
Incidence of Adverse Events, Serious Adverse Events, and Drug-related Adverse Events [Safety and Tolerability] After a Single Dose of ERX-963 vs. Placebo
Drug-related AEs in ERX-963 period
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Incidence of Adverse Events, Serious Adverse Events, and Drug-related Adverse Events [Safety and Tolerability] After a Single Dose of ERX-963 vs. Placebo
TEAEs in Placebo period
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Incidence of Adverse Events, Serious Adverse Events, and Drug-related Adverse Events [Safety and Tolerability] After a Single Dose of ERX-963 vs. Placebo
TEAEs in ERX-963 period
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Incidence of Adverse Events, Serious Adverse Events, and Drug-related Adverse Events [Safety and Tolerability] After a Single Dose of ERX-963 vs. Placebo
Serious Adverse Events
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Incidence of Adverse Events, Serious Adverse Events, and Drug-related Adverse Events [Safety and Tolerability] After a Single Dose of ERX-963 vs. Placebo
Drug-related AEs in Placebo period
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From dosing to approximately 2 hoursPopulation: All treated participants who completed all the protocol specified assessments in both treatment periods were analyzed.
Participants will self-report their level of sleepiness by self-rated questionnaire "Stanford Sleepiness Scale" (SSS). This is a single item questionnaire on a 7-point scale (1-7). Higher values indicate worse outcome.
Outcome measures
| Measure |
Cohort 1: 1 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: Placebo Period
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963 Period
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
|---|---|---|---|---|
|
Assess the Effect of ERX-963 on the Stanford Sleepiness Scale Score Compared to the Effect of Placebo
baseline Stanford Sleepiness Score
|
3.4 score on a scale
Standard Deviation 0.79
|
3.4 score on a scale
Standard Deviation 0.79
|
4.0 score on a scale
Standard Deviation 2.12
|
4.2 score on a scale
Standard Deviation 2.17
|
|
Assess the Effect of ERX-963 on the Stanford Sleepiness Scale Score Compared to the Effect of Placebo
10 min. after end of infusion, SSS
|
3.0 score on a scale
Standard Deviation 0.82
|
2.7 score on a scale
Standard Deviation 1.60
|
4.0 score on a scale
Standard Deviation 1.87
|
3.8 score on a scale
Standard Deviation 2.39
|
|
Assess the Effect of ERX-963 on the Stanford Sleepiness Scale Score Compared to the Effect of Placebo
40 min. after end of infusion, SSS
|
3.1 score on a scale
Standard Deviation 1.57
|
2.9 score on a scale
Standard Deviation 1.68
|
4.2 score on a scale
Standard Deviation 1.92
|
4.0 score on a scale
Standard Deviation 2.45
|
|
Assess the Effect of ERX-963 on the Stanford Sleepiness Scale Score Compared to the Effect of Placebo
1 hr., 10 min. after end of infusion, SSS
|
3.7 score on a scale
Standard Deviation 1.98
|
3.1 score on a scale
Standard Deviation 1.57
|
4.0 score on a scale
Standard Deviation 1.73
|
5.0 score on a scale
Standard Deviation 2.45
|
|
Assess the Effect of ERX-963 on the Stanford Sleepiness Scale Score Compared to the Effect of Placebo
1 hr., 40 min. after end of infusion, SSS
|
3.6 score on a scale
Standard Deviation 1.40
|
3.3 score on a scale
Standard Deviation 0.76
|
4.6 score on a scale
Standard Deviation 1.82
|
5.6 score on a scale
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: Administered at the end of the dosing visit day, upon completion of the other outcome measures. Approximately 2 hours after the end of infusion.Population: All treated participants who completed all the protocol specified assessments in both treatment periods were analyzed.
The PGI-I is a 7-point rating system used by the patient to rate their overall clinical condition after intervention relative to before intervention where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse, and 7=very much worse.
Outcome measures
| Measure |
Cohort 1: 1 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: Placebo Period
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963 Period
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
|---|---|---|---|---|
|
Assess the Effect of ERX-963 on the Change in Patient Global Impression - Improvement Scale (PGI-I) Compared to Placebo
|
3.4 Score of a scale
Standard Deviation 1.27
|
3.4 Score of a scale
Standard Deviation 1.13
|
4.0 Score of a scale
Standard Deviation 2.00
|
4.2 Score of a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Administered at the end of the dosing visit day, upon completion of the other outcome measures. Approximately 2 hours after the end of infusion.Population: All treated participants who completed all the protocol specified assessments in both treatment periods were analyzed.
The CGI-I is a 7-point rating system used by the clinician or investigator to compare the patient's overall clinical condition after intervention relative to before intervention where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse, and 7=very much worse (Guy, 1976; Busner, 2007).
Outcome measures
| Measure |
Cohort 1: 1 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963
n=7 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: Placebo Period
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963 Period
n=5 Participants
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
|---|---|---|---|---|
|
Assess the Effect of ERX-963 on the Clinical Global Impressment - Improvement (CGI-I) Scale Compared to Placebo
|
3.7 Score on a scale
Standard Deviation 1.25
|
3.9 Score on a scale
Standard Deviation 0.90
|
4.0 Score on a scale
Standard Deviation 1.22
|
4.4 Score on a scale
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: From dosing to approximately 2 hoursPopulation: PVT analysis was not performed for this study as this outcome measure analysis requirement was removed in the amended statistical plan. At the end of the clinical study, the project was terminated and the development group was disbanded. The entire team that worked on this project departed and moved on to their new companies. Therefore, this Outcome Measure has zero total analyzed.
Participants will be tested for their response time and number of lapses during the PVT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From dosing to approximately 2 hoursPopulation: One-back task analysis was not performed for this study as this outcome measure analysis requirement was removed in the amended statistical plan. At the end of the clinical study, the project was terminated and the development group was disbanded. The entire team that worked on this project departed and moved on to their new companies. Therefore, this Outcome Measure has zero total analyzed.
Participants will be tested for the proportion of correct response to the One-back task.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Placebo Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1: 1 mg ERX-963 Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Placebo Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: 2 mg ERX-963 Period
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 |
Cohort 1: Placebo Period
n=7 participants at risk
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 1: 1 mg ERX-963 Period
n=7 participants at risk
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 1 mg of ERX-963.
Sequence 2: Participants will receive 1 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: Placebo Period
n=5 participants at risk
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
Cohort 2: 2 mg ERX-963 Period
n=5 participants at risk
The crossover design tests each subject under different treatment conditions allowing for each subject to serve as their own control.
Sequence 1: Participants will receive placebo followed by a washout period. After the washout period, participants will receive 2 mg of ERX-963.
Sequence 2: Participants will receive 2 mg of ERX-963 followed by a washout period. After the washout period, participants will receive placebo.
|
|---|---|---|---|---|
|
Eye disorders
Diplopia
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
20.0%
1/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
|
General disorders
Infusion site pain
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
20.0%
1/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
20.0%
1/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
14.3%
1/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/7 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
20.0%
1/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
0.00%
0/5 • Adverse Events were collected from screening to the End of Study Visit, which was a period of up to 57 days
The adverse event and serious adverse event definition for this study did not differ from the clinicaltrials.gov definitions. Treatment-emergent AEs were AEs which started between the date and time of study drug dosing and through Study Day 2, within each period. Drug-related AEs were assessed by the investigator to determine the relationship (related or unrelated) between the study intervention and each AE occurrence.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Expansion Therapeutics reserves the right to embargo communications regarding trial results prior to public release for a period ≤ 60 days in order to protect patentable information. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed company confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER