Marijuana AbusePhase 1NCT05554926
Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects
A Phase 1 study testing AEF0117 in people with Marijuana Abuse, run by Aelis Farma at 1 site in United States.
Trial summary
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Marijuana Abuse
- What is being tested?
- AEF0117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2022to 24 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males, of any race, between 18 and 65 years of age, inclusive, at screening.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history,12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
- Males will agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of one bowel movement per day.
Who cannot join
- Medical conditions
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to corn products/oil, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy is not allowed.
- Confirmed vital signs measurements below:
- systolic blood pressure >140 or <90 mmHg, systolic blood pressure >160 or <90 mmHg for male volunteers between 60 and 65 years old
Show all 31Show fewer
- diastolic blood pressure >90 or <50 mmHg, and
- pulse rate >100 or <40 beats per minute. Minor deviations from the normal range may be allowed if deemed by the investigator to have no clinical significance, after discussion with medical monitor.
- Positive hepatitis panel and/or reactive human immunodeficiency virus test
- Positive coronavirus disease 2019 (COVID-19) test less than 30 days prior to screening and/or experiencing symptoms.
- Prior/concomitant therapy
- Administration of a COVID-19 vaccine in the past 30 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, and/or use or intend to use any drugs known to induce or inhibit CYP isozymes, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee) and accepted by sponsor's medical monitor.
- Use or intend to use any prescription medications/products within 14 days prior to check-in, and any medication with an elimination half-life of >60 hours (time since last dose of at least 6 times the elimination half-life), unless deemed acceptable by the investigator (or designee) and with consultation with sponsor's medical monitor.
- Use or intend to use slow-release medications/products considered to still be activewithin 14 days prior to check-in, unless deemed acceptable by the investigator (or designee) and accepted by sponsor's medical monitor.
- Use or intend to use any nonprescription medications/products including vitamins,minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days priorto check-in, unless deemed acceptable by the investigator (or designee) and with consultation with sponsor's medical monitor.
- Prior/concurrent clinical study experience
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing, and if the elimination half-life is >60 hours (time since last dose of at least 6 times the elimination half-life), following agreement between investigator (or designee) and sponsor's medical monitor.
- Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator). The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per the US Title 21 CFR 361.1.
- Have previously completed or withdrawn from this study or any other study investigating AEF0117 and have previously received AEF0117.
- Diet and lifestyle
- Alcohol consumption of >21 units per week for males. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen at screening or check-in or positive urine alcohol test result at check-in.
- History of alcoholism or drug/chemical abuse (as defined by the current Diagnostic and Statistical Manual of Mental Disorders) within 2 years prior to check-in.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in or positive cotinine at screening or check-in.
- Other exclusions
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low fat breakfast.
Read the detailed description
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date.
The purpose of this study is to determine the absorption, metabolism, and excretion of [4 14C]AEF0117 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces in healthy male subjects following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the Food and Drug Administration (FDA) Guidance and International Conference on Harmonisation (ICH) M3 and the likelihood of effects of renal or hepatic impairment on the disposition of AEF0117 and the likelihood for drug-drug interactions with AEF0117.
This will be a Phase 1, open-label, nonrandomized, single dose study in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low fat breakfast.
Subjects will reside at the study site from Day -1 through Day 28 and will be discharged on Day 28. If the following criteria are not met by Day 28, subjects will continue study participation and will be asked to return for a residential visit on Day 35 to allow for continuation of the 24-hour collection (urine, blood, and feces) for total radioactivity:
- plasma radioactivity levels below the limit of quantitation for 2 consecutive collections,
- ≥90% mass balance recovery, and
- ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods.
If the following criteria are not met at the Day 35 visit, then the subjects will be required to come back on Day 42 to allow for continuation of the 24-hour collection (urine, blood, and feces) for total radioactivity:
- plasma radioactivity levels below the limit of quantitation for 2 consecutivecollections, and
- ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 24-hour period.
Subjects will be discharged from the study at the latest discharge day of Day 43, unlessotherwise agreed upon by the sponsor and investigator.
Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study.
- Conditions
- Marijuana Abuse
- Being tested
- AEF0117
- Keywords
- AEF0117
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEF0117Drug
Also called 3ß-(4-methoxybenzykoxy)pregn-5-en-20-one t)
2 mg AEF0117 containing approximately 100 μCi of [4-14C]AEF0117
| Study group | Role | What they receive |
|---|---|---|
| [4-14C] AEF0117 | Experimental | Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low-fat breakfast Receives: Drug: AEF0117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine excretion of [4-14C]AEF0117
Fraction excreted (Fe) based on urine collection
Measured: Up to 648 hours post dose
Feces excretion of [4-14C]AEF0117
Fraction excreted (Fe) based on feces collection
Measured: Up to 648 hours post dose
Area under the concentration-time curveof AEF0117
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration;(AUC0-t) based on serial blood sample collections and plasma AEF0117 concentration
Measured: Up to 432 hours postdose
Maximum observed concentration;of AEF0117
Peak Plasma Concentration (Cmax) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration.
Measured: Up to 432 hours postdose
Time of the maximum observed concentration;of AEF0117
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration.
Measured: Up to 432 hours postdose
Apparent terminal elimination half-lifeof AEF0117
Apparent terminal elimination half-life (t1/2); based on serial blood sample collections and plasma AEF0117 concentration.
Measured: Up to 432 hours postdose
Total radioactivity
Measure of total radioactivity in plasma and whole blood
Measured: Up to 1008 hours postdose
Secondary outcomes (4)
Identification of potential metabolites
to determine AEF0117 metabolite profiles based on plasma, urine, and feces excretion
Measured: Up to 984 hours postdose
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Evaluation by grade intensity and by evaluating changes from the baseline in vital signs
Measured: 24 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by ECGs
Evaluation by grade intensity and by evaluating changes from the baseline in ECGs
Measured: 24 hours from dosing
Incidence of laboratory abnormalities
Incidence of laboratory abnormalities based on hematology, clinical chemistry, and urinalysis test results
Measured: Up to 672 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start16 Dec 2022
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana AbuseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of \[4-14C\]AEF0117 approximately 1 hour after completion of a low-fat breakfast. Subjects will reside at the study site from Day -1 through Day 28 and will be discharged on Day 28
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aelis Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irene Mirkin, MD, Principal investigator, Substance Use Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554926
- Sponsor's protocol ID
- AEF0117-106
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05554926
- Acronym / sponsor ID
- AEF0117-106
- Conditions
- Marijuana Abuse
- Keywords
- AEF0117
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aelis FarmaIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 26 Sep 2022 (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.
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low fat breakfast.
Detailed description
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date.
The purpose of this study is to determine the absorption, metabolism, and excretion of [4 14C]AEF0117 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces in healthy male subjects following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the Food and Drug Administration (FDA) Guidance and International Conference on Harmonisation (ICH) M3 and the likelihood of effects of renal or hepatic impairment on the disposition of AEF0117 and the likelihood for drug-drug interactions with AEF0117.
This will be a Phase 1, open-label, nonrandomized, single dose study in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day 1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low fat breakfast.
Subjects will reside at the study site from Day -1 through Day 28 and will be discharged on Day 28. If the following criteria are not met by Day 28, subjects will continue study participation and will be asked to return for a residential visit on Day 35 to allow for continuation of the 24-hour collection (urine, blood, and feces) for total radioactivity:
- plasma radioactivity levels below the limit of quantitation for 2 consecutive collections,
- ≥90% mass balance recovery, and
- ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods.
If the following criteria are not met at the Day 35 visit, then the subjects will be required to come back on Day 42 to allow for continuation of the 24-hour collection (urine, blood, and feces) for total radioactivity:
- plasma radioactivity levels below the limit of quantitation for 2 consecutivecollections, and
- ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 24-hour period.
Subjects will be discharged from the study at the latest discharge day of Day 43, unlessotherwise agreed upon by the sponsor and investigator.
Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low-fat breakfast. Subjects will reside at the study site from Day -1 through Day 28 and will be discharged on Day 28
| Arm | Type | Receives |
|---|---|---|
| [4-14C] AEF0117 | Experimental | Drug: AEF0117Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Up to 8 subjects will be enrolled to ensure that 6 subjects complete the study. Subjects will be admitted into the study site on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 2 mg containing approximately 100 μCi of [4-14C]AEF0117 approximately 1 hour after completion of a low-fat breakfast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males, of any race, between 18 and 65 years of age, inclusive, at screening.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history,12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
- Males will agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Key exclusion criteria (31 listed)
- Medical conditions
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to corn products/oil, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy is not allowed.
- Confirmed vital signs measurements below:
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 |
|---|---|---|
| AEF0117Also: 3ß-(4-methoxybenzykoxy)pregn-5-en-20-one t)2 mg AEF0117 containing approximately 100 μCi of [4-14C]AEF0117 | Drug | [4-14C] AEF0117 |
Primary outcome
Urine excretion of [4-14C]AEF0117
Time frame: Up to 648 hours post dose
Fraction excreted (Fe) based on urine collection
Feces excretion of [4-14C]AEF0117
Time frame: Up to 648 hours post dose
Fraction excreted (Fe) based on feces collection
Area under the concentration-time curveof AEF0117
Time frame: Up to 432 hours postdose
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration;(AUC0-t) based on serial blood sample collections and plasma AEF0117 concentration
Maximum observed concentration;of AEF0117
Time frame: Up to 432 hours postdose
Peak Plasma Concentration (Cmax) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration.
Time of the maximum observed concentration;of AEF0117
Time frame: Up to 432 hours postdose
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration.
Apparent terminal elimination half-lifeof AEF0117
Time frame: Up to 432 hours postdose
Apparent terminal elimination half-life (t1/2); based on serial blood sample collections and plasma AEF0117 concentration.
Total radioactivity
Time frame: Up to 1008 hours postdose
Measure of total radioactivity in plasma and whole blood
4 secondary outcomes
Identification of potential metabolites
Time frame: Up to 984 hours postdose
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Time frame: 24 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by ECGs
Time frame: 24 hours from dosing
Incidence of laboratory abnormalities
Time frame: Up to 672 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Irene Mirkin, MD principal investigator
Substance Use Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AEF0117 in people with Marijuana Abuse, run by Aelis Farma 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 6 inclusion and 31 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 7 Apr 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urine excretion of [4-14C]AEF0117 (time frame: Up to 648 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 7 Apr 2023.