Ethanol Intoxication
Conditions
Keywords
Aldeyra, ADX-629
Brief summary
A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels
Interventions
DRUGADX-629
3 oral doses of ADX-629 600 milligrams
DRUGPlacebo
3 oral doses of placebo
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening; 2. Subjects with the ability to obtain transportation to and from the study site; 3. Subjects who agree to abstain from consumption of non-study alcohol during the study.
Exclusion criteria
1. Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening; 2. Subjects with nicotine product use within 14 days prior to Screening until the end of the study; 3. Subjects with any history of or current alcohol or other substance use disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; 4. Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events | The safety assessment period was approximately two days for each treatment period. | Safety was assessed through serious adverse event collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Dermal Flushing | The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period. | Dermal flushing was assessed on a 0 to 100 scale (0 = none, 100 = extremely severe). Change from baseline was analyzed using mixed model for repeated measures (MMRM), with baseline and emesis volume as covariates, and sequence, period, time point, and treatment as factors. |
| Change From Baseline for Romberg Test | The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period. | Romberg Test was assessed for up to 60 seconds. Subjects stood with feet together and eyes closed, and the length of time the subject was able to stand without movement was recorded. Change from baseline was analyzed using MMRM, with baseline, number of bodyweight-standardized drinks consumed, and blood alcohol concentration as covariates, and sequence, period, time point, treatment, and the interaction of treatment by time point as factors. |
Countries
United States
Participant flow
Pre-assignment details
Twenty-six subjects were randomized in a crossover design. On Day 1 for each treatment period, subjects were dosed followed by ethanol consumption. Approximately three hours later, subjects were administered a second dose followed by continued ethanol consumption to reach a target blood alcohol concentration of 0.14 g/100mL, at which time assessments were conducted. On Day 2, subjects were dosed once and assessments were completed approximately two hours and five hours after dosing.
Participants by arm
| Arm | Count |
|---|---|
| ADX-629 First, Then Placebo Subjects received three oral doses of ADX-629 600mg over two consecutive days, followed by a fourteen-day washout. Subjects then received three oral doses of placebo over two consecutive days. | 12 |
| Placebo First, Then ADX-629 Subjects received three oral doses of placebo over two consecutive days, followed by a fourteen-day washout. Subjects then received three oral doses of ADX-629 600mg over two consecutive days. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | ADX-629 First, Then Placebo | Placebo First, Then ADX-629 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 14 Participants | 26 Participants |
| Age, Continuous | 44.1 years STANDARD_DEVIATION 9 | 41.1 years STANDARD_DEVIATION 12.4 | 42.5 years STANDARD_DEVIATION 10.8 |
| Body Mass Index | 26.4 kg/m2 STANDARD_DEVIATION 3 | 26.6 kg/m2 STANDARD_DEVIATION 3.5 | 26.5 kg/m2 STANDARD_DEVIATION 3.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 15 / 23 | 21 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events
Safety was assessed through serious adverse event collection.
Time frame: The safety assessment period was approximately two days for each treatment period.
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADX-629 | Number of Subjects With Serious Adverse Events | 0 Participants |
| Placebo | Number of Subjects With Serious Adverse Events | 0 Participants |
Secondary
Change From Baseline for Romberg Test
Romberg Test was assessed for up to 60 seconds. Subjects stood with feet together and eyes closed, and the length of time the subject was able to stand without movement was recorded. Change from baseline was analyzed using MMRM, with baseline, number of bodyweight-standardized drinks consumed, and blood alcohol concentration as covariates, and sequence, period, time point, treatment, and the interaction of treatment by time point as factors.
Time frame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Population: Intent-to-treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ADX-629 | Change From Baseline for Romberg Test | -0.04 seconds | Standard Error 1.25 |
| Placebo | Change From Baseline for Romberg Test | -1.42 seconds | Standard Error 1.2 |
Secondary
Change From Baseline of Dermal Flushing
Dermal flushing was assessed on a 0 to 100 scale (0 = none, 100 = extremely severe). Change from baseline was analyzed using mixed model for repeated measures (MMRM), with baseline and emesis volume as covariates, and sequence, period, time point, and treatment as factors.
Time frame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Population: Intent-to-treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ADX-629 | Change From Baseline of Dermal Flushing | -4.02 score on a scale | Standard Error 0.44 |
| Placebo | Change From Baseline of Dermal Flushing | 1.15 score on a scale | Standard Error 1.37 |