Ethanol IntoxicationPhase 1/2NCT05487404
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
A Phase 1/2 study testing ADX-629 in people with Ethanol Intoxication, run by Aldeyra Therapeutics, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Ethanol Intoxication
- What is being tested?
- ADX-629
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 29 May 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;
- Subjects with the ability to obtain transportation to and from the study site;
- Subjects who agree to abstain from consumption of non-study alcohol during the study.
Who cannot join
- Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;
- Subjects with nicotine product use within 14 days prior to Screening until the end of the study;
- 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;
- Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45230
About this study
Official title: A Double-Blind Clinical 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
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
- Conditions
- Ethanol Intoxication
- Being tested
- ADX-629, Placebo
- Keywords
- Aldeyra, ADX-629
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-629Drug
3 oral doses of ADX-629 600 milligrams
PlaceboDrug
3 oral doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| ADX-629 Oral Tablets | Experimental | Not described Receives: Drug: ADX-629 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serious Adverse Events
Safety was assessed through serious adverse event collection.
Measured: The safety assessment period was approximately two days for each treatment period.
Secondary outcomes (2)
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.
Measured: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
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.
Measured: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start15 Nov 2021
- Primary completion29 May 2022
- Study completion29 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ethanol IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487404
- Sponsor's protocol ID
- ADX-629-ET-001
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2022
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Clinical 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
- ClinicalTrials.gov ID
- NCT05487404
- Acronym / sponsor ID
- ADX-629-ET-001
- Conditions
- Ethanol Intoxication
- Keywords
- Aldeyra, ADX-629
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX-629 Oral Tablets | Experimental | Drug: ADX-629 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;
- Subjects with the ability to obtain transportation to and from the study site;
- Subjects who agree to abstain from consumption of non-study alcohol during the study.
Key exclusion criteria (4 listed)
- Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;
- Subjects with nicotine product use within 14 days prior to Screening until the end of the study;
- 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;
- Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-6293 oral doses of ADX-629 600 milligrams | Drug | ADX-629 Oral Tablets |
| Placebo3 oral doses of placebo | Drug | Placebo |
Primary outcome
Number of Subjects With Serious Adverse Events
Time frame: The safety assessment period was approximately two days for each treatment period.
Safety was assessed through serious adverse event collection.
2 secondary outcomes
Change From Baseline of Dermal Flushing
Time frame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Change From Baseline for Romberg Test
Time frame: The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ethanol Intoxication
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
Not yet recruitingPhase 1
The Impact of Dose on the Impairing, Intoxicating, and Abuse-Related Effects of Psilocybin
Psilocybin Intoxication
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADX-629 in people with Ethanol Intoxication, run by Aldeyra Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Serious Adverse Events (time frame: The safety assessment period was approximately two days for each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.