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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-629 Oral Tablets | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-629 | Drug | 3 oral doses of ADX-629 600 milligrams |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serious Adverse Events | Safety was assessed through serious adverse event collection. | The safety assessment period was approximately two days for each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology | Cincinnati | Ohio | 45230 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo First, Then ADX-629 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Serious Adverse Events | Safety was assessed through serious adverse event collection. | Safety Population | Posted | Count of Participants | Participants | The safety assessment period was approximately two days for each treatment period. |
|
Two days for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADX-629 | Three oral doses of ADX-629 600mg over two consecutive days | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2022 | Jan 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2022 | Jan 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000716647 | ADX-629 |
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| Placebo |
| Drug |
3 oral doses of placebo |
|
| 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. | The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Units | Counts |
|---|
| Participants |
|
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| 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | score on a scale | The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period. |
|
|
|
| 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. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | seconds | The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period. |
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|
|
| 23 |
| 0 |
| 23 |
| 15 |
| 23 |
| EG001 | Placebo | Three oral doses of placebo over two consecutive days | 0 | 25 | 0 | 25 | 21 | 25 |
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | Gastrointestinal disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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