Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels (NCT NCT05487404)
NCT ID: NCT05487404
Last Updated: 2025-02-28
Results Overview
Safety was assessed through serious adverse event collection.
COMPLETED
PHASE1/PHASE2
26 participants
The safety assessment period was approximately two days for each treatment period.
2025-02-28
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
Baseline characteristics by cohort
| Measure |
ADX-629 First, Then Placebo
n=12 Participants
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.
|
Placebo First, Then ADX-629
n=14 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index
|
26.4 kg/m2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
26.6 kg/m2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
26.5 kg/m2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: The safety assessment period was approximately two days for each treatment period.Population: Safety Population
Safety was assessed through serious adverse event collection.
Outcome measures
| Measure |
ADX-629
n=23 Participants
Three oral doses of ADX-629 600mg over two consecutive days
|
Placebo
n=25 Participants
Three oral doses of placebo over two consecutive days
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ADX-629
n=23 Participants
Three oral doses of ADX-629 600mg over two consecutive days
|
Placebo
n=25 Participants
Three oral doses of placebo over two consecutive days
|
|---|---|---|
|
Change From Baseline of Dermal Flushing
|
-4.02 score on a scale
Standard Error 0.44
|
1.15 score on a scale
Standard Error 1.37
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
ADX-629
n=23 Participants
Three oral doses of ADX-629 600mg over two consecutive days
|
Placebo
n=25 Participants
Three oral doses of placebo over two consecutive days
|
|---|---|---|
|
Change From Baseline for Romberg Test
|
-0.04 seconds
Standard Error 1.25
|
-1.42 seconds
Standard Error 1.20
|
Adverse Events
ADX-629
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ADX-629
n=23 participants at risk
Three oral doses of ADX-629 600mg over two consecutive days
|
Placebo
n=25 participants at risk
Three oral doses of placebo over two consecutive days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/23 • Two days for each intervention
|
4.0%
1/25 • Number of events 1 • Two days for each intervention
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
2/23 • Number of events 2 • Two days for each intervention
|
8.0%
2/25 • Number of events 2 • Two days for each intervention
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
1/23 • Number of events 1 • Two days for each intervention
|
0.00%
0/25 • Two days for each intervention
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • Number of events 11 • Two days for each intervention
|
56.0%
14/25 • Number of events 14 • Two days for each intervention
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
7/23 • Number of events 20 • Two days for each intervention
|
28.0%
7/25 • Number of events 14 • Two days for each intervention
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/23 • Two days for each intervention
|
4.0%
1/25 • Number of events 1 • Two days for each intervention
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • Two days for each intervention
|
4.0%
1/25 • Number of events 1 • Two days for each intervention
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • Two days for each intervention
|
4.0%
1/25 • Number of events 1 • Two days for each intervention
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Two days for each intervention
|
4.0%
1/25 • Number of events 1 • Two days for each intervention
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2 • Two days for each intervention
|
12.0%
3/25 • Number of events 3 • Two days for each intervention
|
|
Nervous system disorders
Headache
|
52.2%
12/23 • Number of events 12 • Two days for each intervention
|
56.0%
14/25 • Number of events 14 • Two days for each intervention
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.3%
1/23 • Number of events 1 • Two days for each intervention
|
0.00%
0/25 • Two days for each intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place