A Phase I Study of the Interaction of Alcohol With Oral AFA-281 in Healthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorAfasci Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
AFA-281 is a small molecule, orally available
DrugThis is a study to evaluate the interaction of AFA-281 with alcohol
Alcohol (Ethanol)
Other interventionAlcohol will be administered in combination with AFA-281 or AFA-281 placebo
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: AFA-281 with EthanolActive comparator 2 interventions
Group B: AFA-281 with Ethanol PlaceboPlacebo comparator 1 intervention
Group C: AFA-281 placebo with EthanolPlacebo comparator 1 intervention
Group D: AFA-281 placebo with Ethanol placeboSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pharmacokinetic evaluation of AFA-281
Evaluation of AFA-281 concentrations in the blood over time
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 dose2
Evaluation of ethanol levels in the blood
Measure ethanol concentrations in the blood over time
Time frame
Collected at 2, 2.25, 2.5, 2.75, 3, 3.25, 4, 5, 6, 7, 8, 12 and 24 hours post administration3
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
Time frame
Collected at predose, 1, 2, 3, 4, 6 and 8 hours post dose4
Choice Reaction Time (CRT) evaluation
Central nervous system test. The subject is required to respond to one stimulus, the quicker the better
Time frame
Predose and 1, 2, 3, 4, 6 and 8 hours post doseSecondary outcomes
1
Clinical chemistry
Blood test for metabolic panel
Time frame
Baseline, pre-intervention and in 24 hours after completion of the intervention2
A complete blood count (CBC) with differential
complete blood count with differential
Time frame
Baseline, pre-intervention and in 24 hours after completion of the intervention3
Heart Rate
Measurement of heart rate
Time frame
Predose, 1, 2, 4 hours post dose4
Blood pressure, both systolic, and diastolic pressure
Measurement of blood pressure
Time frame
Predose, 1, 2, 4 hours post doseLocations
Source ClinicalTrials.gov
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