A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers
NCT ID: NCT06719908
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-07-01
2029-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AFA-281 with 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 is a small molecule, orally available
This is a study to evaluate the interaction of AFA-281 with alcohol
Alcohol (Ethanol)
Alcohol will be administered in combination with AFA-281 or AFA-281 placebo
AFA-281 with Ethanol Placebo
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).
AFA-281 is a small molecule, orally available
This is a study to evaluate the interaction of AFA-281 with alcohol
AFA-281 placebo with 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).
Alcohol (Ethanol)
Alcohol will be administered in combination with AFA-281 or AFA-281 placebo
AFA-281 placebo with Ethanol placebo
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).
AFA-281 is a small molecule, orally available
This is a study to evaluate the interaction of AFA-281 with alcohol
Alcohol (Ethanol)
Alcohol will be administered in combination with AFA-281 or AFA-281 placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AFA-281 is a small molecule, orally available
This is a study to evaluate the interaction of AFA-281 with alcohol
Alcohol (Ethanol)
Alcohol will be administered in combination with AFA-281 or AFA-281 placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
21 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Afasci Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AFA-281-303
Identifier Type: -
Identifier Source: org_study_id