AlcoholPhase 1NCT06719908
A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers
A Phase 1 study testing AFA-281 is a small molecule, orally available and Alcohol (Ethanol) in people with Alcohol and Alcohol Use Disorders, run by Afasci Inc.
Trial summary
The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol, Alcohol Use Disorders
- What is being tested?
- AFA-281 is a small molecule, orally available and Alcohol (Ethanol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 21 and 55 years of age, inclusive.
- Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
- Currently consumes alcohol regularly (defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least one occasion in the 30 days prior to screening) but does not meet the DSM-5 criteria for Alcohol Use Disorder. Note: one standard alcoholic drink is equivalent to 1.5 oz. hard liquor or 5 oz. wine or 12 oz. beer.
- Body mass index (BMI) within the range of 18.5 to 30.0 kg/m2, inclusive.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit
- Adequate venous access
- Must be surgically sterile (vasectomy, tubal ligation or hysterectomy) or agree to be sexually inactive or agree to use a barrier method of birth control (i.e., condom) from the start of screening until study completion, and agree to refrain from donating sperm, for 90 days after study drug administration.
- Agree to abstain from strenuous exercise during the inpatient stay of the study.
Who cannot join
- History of significant sensitivity to any drug.
- Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) > 430 msec.
- Has an estimated creatinine clearance (CrCl) outside of normal range.
- History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.
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- Use of any medications, vitamins and/or herbal supplements within the 2-week period prior to study drug administration.
- Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
- Display any latent signs of alcohol withdrawal per the Clinical Institute Withdrawal of Alcohol Assessment-Revised (CIWA-AR).
- History or current diagnosis of a substance use disorder.
- Positive urine drug screen for drugs of abuse at Screening or Day -1.
- Consumption of alcohol within the 1-day period prior to study drug administration.
- Receipt of any drug by injection within 30 days prior to study drug administration.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine, dermatological, metabolic or psychiatric disease or disorder, or any uncontrolled medical illness.
- A clinically notable vital sign abnormality including a history of syncopal or near syncopal events following abrupt change in posture.
- History of cardiac disease, including family history of long-QT syndrome, second degree heart block Type II, third degree heart block or unexplained sudden deaths in their family.
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration.
- Pregnant or nursing women
- Receipt of any investigational product within 6 weeks prior to study drug administration.
- Consumption of grapefruit or grapefruit products from 3 days prior to study drug administration.
- Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
- Previous enrollment in this study.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive AFA-281.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers
The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.
Participants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, 4-way crossover study of the interaction of alcohol and oral AFA-281 in healthy adult volunteers. This study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of co-administration of AFA-281 and ethanol in healthy, male and female subjects who are social or moderate drinkers but do not meet criteria for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Alcohol Use Disorder. Each subject will receive single doses of AFA-281, ethanol, placebo for AFA-481, and placebo for ethanol in a randomized, double-blind, crossover manner. Randomized blocks will be included to ensure that there is 1 day in between treatment sessions. Blood will be collected for PK and blood alcohol levels at pre-dose and at multiple timepoints after treatment. Safety parameters will be evaluated for tolerability such as vital signs and clinical pathology. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.
- Conditions
- Alcohol, Alcohol Use Disorders
- Being tested
- AFA-281 is a small molecule, orally available, Alcohol (Ethanol)
- Keywords
- AFA-281, Alcohol, Ethanol, Healthy Volunteer
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFA-281 is a small molecule, orally availableDrug
This is a study to evaluate the interaction of AFA-281 with alcohol
Alcohol (Ethanol)Other
Alcohol will be administered in combination with AFA-281 or AFA-281 placebo
| Study group | Role | What they receive |
|---|---|---|
| AFA-281 with Ethanol | Active comparator | AFA-281 (40 mg) will be administered as a single dose (oral) in combination with Alcohol (0.6 g/kg in females or 0.7g/kg in males). Receives: Drug: AFA-281 is a small molecule, orally available; Other: Alcohol (Ethanol) |
| AFA-281 with Ethanol Placebo | Placebo comparator | AFA-281 (40 mg) will be administered as a single dose (oral) in combination with the Alcohol placebo (0.6 g/kg in females or 0.7g/kg in males). Receives: Drug: AFA-281 is a small molecule, orally available |
| AFA-281 placebo with Ethanol | Placebo comparator | AFA-281 placebo (40 mg) will be administered as a single dose (oral) in combination with the Alcohol (0.6 g/kg in females or 0.7g/kg in males). Receives: Other: Alcohol (Ethanol) |
| AFA-281 placebo with Ethanol placebo | Sham comparator | AFA-281 placebo (40 mg) will be administered as a single dose (oral) in combination with the Alcohol placebo (0.6 g/kg in females or 0.7g/kg in males). Receives: Drug: AFA-281 is a small molecule, orally available; Other: Alcohol (Ethanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic evaluation of AFA-281
Evaluation of AFA-281 concentrations in the blood over time
Measured: Predose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 4, 5, 6, 7, 8, 12 and 24 hours post dose
Evaluation of ethanol levels in the blood
Measure ethanol concentrations in the blood over time
Measured: Collected at 2, 2.25, 2.5, 2.75, 3, 3.25, 4, 5, 6, 7, 8, 12 and 24 hours post administration
Dizziness visual analog scale (VAS) assessment
Central nervous system test. Visual Analogue Scale for dizziness assessment on a scale 0 to 10. 0 no dizziness and 10 worst
Measured: Collected at predose, 1, 2, 3, 4, 6 and 8 hours post dose
Choice Reaction Time (CRT) evaluation
Central nervous system test. The subject is required to respond to one stimulus, the quicker the better
Measured: Predose and 1, 2, 3, 4, 6 and 8 hours post dose
Balance Platform assessment
Central nervous system test. Balance platform assessment
Measured: Predose and 1, 2, 3, 4, 6 and 8 hours post dose
Match to Sample Visual Search (MTS) assessments
Central nervous system test. Assesses attention and visual searching, with a speed accuracy trade-off. The quicker, the better.
Measured: 1, 2, 4 and 8 hours post dose
Alertness visual analog scale (AVAS)
Central nervous system test. Asks a subject to indicate their feelings on a line with a scale from 0 mm on the left to 100 mm on the right. The scale can be used to assess sleepiness and other subjective experiences.
Measured: 1, 2, 4 and 8 hours post dose
Secondary outcomes (6)
Clinical chemistry
Blood test for metabolic panel
Measured: Baseline, pre-intervention and in 24 hours after completion of the intervention
A complete blood count (CBC) with differential
complete blood count with differential
Measured: Baseline, pre-intervention and in 24 hours after completion of the intervention
Heart Rate
Measurement of heart rate
Measured: Predose, 1, 2, 4 hours post dose
Blood pressure, both systolic, and diastolic pressure
Measurement of blood pressure
Measured: Predose, 1, 2, 4 hours post dose
Body weight
Measurement of body weight
Measured: Baseline, pre-intervention and after in 24 hours of the intervention
Electrocardiogram (ECG) including P Wave, QRS Complex, and QT Interval, etc.)
ECG assessment
Measured: Baseline, pre-intervention and 2 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afasci Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719908
- Sponsor's protocol ID
- AFA-281-303
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06719908
- Acronym / sponsor ID
- AFA-281-303
- Conditions
- Alcohol, Alcohol Use Disorders
- Keywords
- AFA-281, Alcohol, Ethanol, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Afasci IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate if alcohol interacts with the drug candidate AFA-281 in adults (healthy volunteers). This trial will evaluate blood concentration levels of AFA-281 and ethanol. The main questions it aims to answer are: Does alcohol interact with AFA-281? What are the side effects (if any)? Researchers will compare AFA-281 to a placebo (a look-alike substance that contains no drug) to see if AFA-281 interacts with alcohol.
Participants will take a total of 4 treatment sessions separated by at least 2 days between treatments. The treatments will incorporate AFA-281 or placebo with ethanol or ethanol placebo. After each treatment vital signs will be monitored and blood collected to measure AFA-281 and ethanol levels. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.
Detailed description
This is a randomized, double-blind, placebo-controlled, 4-way crossover study of the interaction of alcohol and oral AFA-281 in healthy adult volunteers. This study will evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of co-administration of AFA-281 and ethanol in healthy, male and female subjects who are social or moderate drinkers but do not meet criteria for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of Alcohol Use Disorder. Each subject will receive single doses of AFA-281, ethanol, placebo for AFA-481, and placebo for ethanol in a randomized, double-blind, crossover manner. Randomized blocks will be included to ensure that there is 1 day in between treatment sessions. Blood will be collected for PK and blood alcohol levels at pre-dose and at multiple timepoints after treatment. Safety parameters will be evaluated for tolerability such as vital signs and clinical pathology. Participants will provide an assessment survey of symptoms. The total treatment time will be 9 inpatient days (8 nights), and a final follow-up visit 3 to 5 days after clinic discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AFA-281 with Ethanol | Active comparator | Drug: AFA-281 is a small molecule, orally available, Other: Alcohol (Ethanol)AFA-281 (40 mg) will be administered as a single dose (oral) in combination with Alcohol (0.6 g/kg in females or 0.7g/kg in males). |
| AFA-281 with Ethanol Placebo | Placebo comparator | Drug: AFA-281 is a small molecule, orally availableAFA-281 (40 mg) will be administered as a single dose (oral) in combination with the Alcohol placebo (0.6 g/kg in females or 0.7g/kg in males). |
| AFA-281 placebo with Ethanol | Placebo comparator | Other: Alcohol (Ethanol)AFA-281 placebo (40 mg) will be administered as a single dose (oral) in combination with the Alcohol (0.6 g/kg in females or 0.7g/kg in males). |
| AFA-281 placebo with Ethanol placebo | Sham comparator | Drug: AFA-281 is a small molecule, orally available, Other: Alcohol (Ethanol)AFA-281 placebo (40 mg) will be administered as a single dose (oral) in combination with the Alcohol placebo (0.6 g/kg in females or 0.7g/kg in males). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults between 21 and 55 years of age, inclusive.
- Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
- Currently consumes alcohol regularly (defined as having consumed 7 to 21 standard drinks per week on average in the 6 months prior to screening and having consumed ≥5 standard drinks on at least one occasion in the 30 days prior to screening) but does not meet the DSM-5 criteria for Alcohol Use Disorder. Note: one standard alcoholic drink is equivalent to 1.5 oz. hard liquor or 5 oz. wine or 12 oz. beer.
- Body mass index (BMI) within the range of 18.5 to 30.0 kg/m2, inclusive.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) at the screening visit
Key exclusion criteria (24 listed)
- History of significant sensitivity to any drug.
- Has a clinically significant abnormal ECG or an ECG with a QTc interval corrected for heart rate using the Fridericia formula (QTcF) > 430 msec.
- Has an estimated creatinine clearance (CrCl) outside of normal range.
- History of head trauma with loss of consciousness, seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
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 |
|---|---|---|
| AFA-281 is a small molecule, orally availableThis is a study to evaluate the interaction of AFA-281 with alcohol | Drug | AFA-281 placebo with Ethanol placebo, AFA-281 with Ethanol, AFA-281 with Ethanol Placebo |
| Alcohol (Ethanol)Alcohol will be administered in combination with AFA-281 or AFA-281 placebo | Other | AFA-281 placebo with Ethanol, AFA-281 placebo with Ethanol placebo, AFA-281 with Ethanol |
Primary outcome
Pharmacokinetic evaluation of AFA-281
Time frame: Predose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 4, 5, 6, 7, 8, 12 and 24 hours post dose
Evaluation of AFA-281 concentrations in the blood over time
Evaluation of ethanol levels in the blood
Time frame: Collected at 2, 2.25, 2.5, 2.75, 3, 3.25, 4, 5, 6, 7, 8, 12 and 24 hours post administration
Measure ethanol concentrations in the blood over time
Dizziness visual analog scale (VAS) assessment
Time frame: Collected at predose, 1, 2, 3, 4, 6 and 8 hours post dose
Central nervous system test. Visual Analogue Scale for dizziness assessment on a scale 0 to 10. 0 no dizziness and 10 worst
Choice Reaction Time (CRT) evaluation
Time frame: Predose and 1, 2, 3, 4, 6 and 8 hours post dose
Central nervous system test. The subject is required to respond to one stimulus, the quicker the better
Balance Platform assessment
Time frame: Predose and 1, 2, 3, 4, 6 and 8 hours post dose
Central nervous system test. Balance platform assessment
Match to Sample Visual Search (MTS) assessments
Time frame: 1, 2, 4 and 8 hours post dose
Central nervous system test. Assesses attention and visual searching, with a speed accuracy trade-off. The quicker, the better.
Alertness visual analog scale (AVAS)
Time frame: 1, 2, 4 and 8 hours post dose
Central nervous system test. Asks a subject to indicate their feelings on a line with a scale from 0 mm on the left to 100 mm on the right. The scale can be used to assess sleepiness and other subjective experiences.
6 secondary outcomes
Clinical chemistry
Time frame: Baseline, pre-intervention and in 24 hours after completion of the intervention
A complete blood count (CBC) with differential
Time frame: Baseline, pre-intervention and in 24 hours after completion of the intervention
Heart Rate
Time frame: Predose, 1, 2, 4 hours post dose
Blood pressure, both systolic, and diastolic pressure
Time frame: Predose, 1, 2, 4 hours post dose
Body weight
Time frame: Baseline, pre-intervention and after in 24 hours of the intervention
Electrocardiogram (ECG) including P Wave, QRS Complex, and QT Interval, etc.)
Time frame: Baseline, pre-intervention and 2 hours post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFA-281 is a small molecule, orally available and Alcohol (Ethanol) in people with Alcohol and Alcohol Use Disorders, run by Afasci Inc.
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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Xie, MD (650-995-7320, simonxie@afasci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic evaluation of AFA-281 (time frame: Predose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 4, 5, 6, 7, 8, 12 and 24 hours post dose). The study lists 7 primary outcomes in all. 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 6 Dec 2024.