Healthy VolunteersPhase 1NCT03325595
Single Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117
A Phase 1 study testing AEF0117 in people with Healthy Volunteers, run by Aelis Farma at 1 site in United States.
Trial summary
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AEF0117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2017to 26 Feb 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a healthy, non-smoking or smoking (<10 cigarettes per day) male of any race, at least 18 years old and no more than 55 years old, inclusive. As the effect of the study drug on sperm is still unknown, male subjects should refrain from donating sperm or plan a pregnancy with their partner throughout the study and after 90 days, and must report immediately to the study doctor if its partner becomes pregnant during the study and after 90 days. The male subject will have to use double-barrier contraceptive methods: male condoms and spermicide.
- Be a healthy, non-smoking or smoking (<10 cigarettes per day) female of non-child-bearing potential between 18 years of age and 55 years of age, inclusive. Females may be accepted if they are documented to be surgically sterile (e.g., hysterectomy, tubal ligation) or post-menopausal [amenorrhea >1 year and FSH >25.8mlU/mL, cut off from Labcorp] with a negative pregnancy test. At least 30% of female.
- Have a body weight ≥50 kg, with a body mass index (BMI) calculated as weight in kg/(height in m)2 from 18 to 30 kg/m2 (inclusive) at screening.
- Have no significant diseases in the medical history and no clinically significant findings on physical examination including ECG, BP, HR, RR, temperature, C-SSRS test. Routine laboratory values should be within normal ranges or considered as NCS by the investigator. The Non Clinical Significant nature of the deviation will result from the integration of a full clinical examination with physical examination and lab tests in that contest by a certified physician.
- Be informed of the nature of the study and provide written informed consent.
- Be legally competent and able to communicate effectively with study personnel.
Who cannot join
- Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients and known allergies to pregnenolone or its matching placebo or its ingredient
- Acute signs of intoxication at screening or baseline assessment due to opiates or any type of stimulants, causing cognitive impairments
- Severe learning disability, brain damage or pervasive developmental disorder ( as this may affect one of the end point that is being targeted)
- Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- Have abnormal baseline values for the steroid hormones: cortisol, testosterone, estradiol and progesterone in accordance to their reproductive status (for example but not limited to surgical sterile or post-menopausal).
- A history of alcoholism or drug addiction within the past 2 years, recent use (in the last month) of any recreational drugs, or positive results from a urine screen for substances of abuse or from an alcohol breath test.
Show all 19Show fewer
- A history of or current serious mental illness including active or recent suicidal ideation, severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder) or/and an abnormal C-SSRS result.
- A history of difficulty donating blood or inadequate venous access.
- The donation of blood or plasma within 30 days prior to receiving study medication or received any blood and plasma for medical/surgical reasons or intention to donate blood or plasma within one month after receiving the study drug.
- A positive hepatitis screen that tests for both hepatitis B surface antigen (HBsAg) and antibody to hepatitis C (HCV).
- A positive test result for HIV antibody by enzyme immunoassay which is confirmed by Western immunoblot.
- Ingestion of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication (for investigational drugs with an elimination half-life greater than 10 days, this will be extended to 60 days).
- Use of any prescription or over-the-counter (OTC) drug therapy, including herbal, homeopathic, vitamins, minerals and nutritional supplements, bodybuilding supplements unapproved by the sponsor, within 2 weeks prior to receiving the study medication (for drugs with an elimination half-life greater than 10 days, this will be extended to 60 days). The use of any food supplement or body cream containing pregnenolone or any other steroid including phytosteroids.
- Use of a drug therapy known to induce or inhibit hepatic drug metabolism within 30 days prior to receiving study medication or during the study.
- Use of psychoactive and/or psychotropic medication (including sedative, antidepressant and antipsychotics), or medication that alters the hypothalamic pituitary adrenal (HPA) Axis functioning and any medications that alter heart rate or skin conductance monitoring.
- Unable to follow the restrictions outlined in the protocol.
- Legal status that would interfere with participation.
- Employed by the contract research organization (CRO) or are family members of the staff at the CRO.
- Previous participation in a cohort for any dose level of AEF0117.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Center, Double-blind, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of Single Oral Doses of AEF0117 in Healthy Male and Female Subjects
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects.
Read the detailed description
The overall goal of this protocol is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects. This will be a single center study in healthy adult male and female subjects. The study design will be a double-blind, randomized, placebo-controlled, single period, parallel group, single dose escalation with AEF0117.
Four dose levels are planned for the study with 8 subjects (6 active and 2 placebo, 3:1 ratio) per dose level:
Dose Level I - 0.2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level II - 0.6 mg single oral dose of AEF0117given on the morning of Day 1 Dose Level III - 2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level IV - 6 mg single oral dose of AEF0117 given on the morning of Day 1 The planned dose escalation schema may be amended based on the emerging PK and safety data. Each subject will participate in only one dose group.
In each dosing cohort, 2 sentinel subjects (randomized 1 AEF0117: 1placebo) will be dosed and observed for safety monitoring for 24 hours prior to initiating dosing in the remaining 6 subjects (randomized 5 AEF0117: 1 placebo).
The first cohort will be administered 0.2mg. Administration of AEF0117 to the subsequent dose cohorts,0.6 mg(Cohort II), 2 mg (Cohort III), and 6 mg (Cohort IV) doses should not occur before participants in the previous dose cohort have been treated and data i.e. safety results from those participants are reviewed in accordance with the protocol.
Serial blood sample collections will be performed for 144 hours after dose administration for PK analysis, and for 48 hours after dose administration for PD analysis.
Subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and remain in-house until Day 8. Randomized subjects will receive a single dose of AEF0117 on Day 1. PK samples and safety assessments will be performed pre-dose and at different times post dose. Safety monitoring (physical examinations, vital sign measurement, 12-lead electrocardiograms [ECGs], clinical safety laboratory tests, and adverse event monitoring) will be performed throughout the study. Psychometrics (Bond \& Lader VAS, ARCI, POMS) and C-SSRS tests will be performed.
- Conditions
- Healthy Volunteers
- Being tested
- AEF0117, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEF0117Drug
0.2, 0.6, 2, or 6mg of AEF0117
PlaceboDrug
Matching capsule placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AEF0117 | Active comparator | Subjects in Cohorts 1 through 4 receive active treatments. Subjects in Cohorts 1 through 4 will receive a single dose of 0.2, 0.6, 2 and 6mg respectively of AEF0117 on Day1. Receives: Drug: AEF0117 |
| Placebo Comparator: Placebo | Placebo comparator | Subjects in Cohorts 1 through 4 will be randomly assigned in an 6:2 allocation to receive active or placebo treatments. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 168 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: 168 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by clinical laboratory values
Evaluation by grade intensity and by evaluating changes from the baseline in clinical laboratory values from blood and urine samples.
Measured: 168 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by psychometric tests
Evaluation by grade intensity and by evaluating changes from the baseline in psychometric tests (Bond and Lader VAS, ARCI, POMS) and C-SSRS test.
Measured: 36 hours from dosing
Secondary outcomes (10)
Pharmacokinetics of escalating single oral doses of AEF0117
Peak Plasma Concentration (Cmax) induced by a single dose of AEF0117will be determined based on serial blood sample collections and plasma AEF0117 concentration.
Measured: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Lowest Peak Plasma (Cmin) induced by a single dose of AEF0117 will be determined based on serial blood sample collections and plasma AEF0117 concentration.
Measured: 144 hours from dosing
Pharmacokinetics of escalating single oral doses 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: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Terminal elimination half-life (t1/2) based on serial blood sample collections and plasma AEF0117 concentration.
Measured: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Time to last measurable plasma concentration (tlast) based on serial blood sample collections and plasma AEF0117 concentration.
Measured: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Area under the plasma concentration versus time curve from time 0 (AUC0-t) based on serial blood sample collections and plasma AEF0117 concentration.
Measured: 144 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Peak Plasma Concentration (Cmax) induced by a single dose of AEF0117 on plasma pregnenolone, 17-OH-pregnenolone, DHEA, allopregnanolone, testosterone and endocannabinoids (AEA and 2AG) and serum estradiol, progesterone and cortisol concentrations.
Measured: 48 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Lowest Peak Plasma (Cmin) induced by a single dose of AEF0117 on plasma pregnenolone, 17-OH-pregnenolone, DHEA, allopregnanolone, testosterone and endocannabinoids (AEA and 2AG) and serum estradiol, progesterone and cortisol concentrations.
Measured: 48 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Time to maximum plasma concentration (tmax) of a single dose of AEF0117 on plasma pregnenolone, 17-OH-pregnenolone, DHEA, allopregnanolone, testosterone and endocannabinoids (AEA and 2AG) and serum estradiol, progesterone and cortisol concentrations.
Measured: 48 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Area under the plasma concentration versus time curve from time 0 (AUC0-t) of a single dose of AEF0117 on plasma pregnenolone, 17-OH-pregnenolone, DHEA, allopregnanolone, testosterone and endocannabinoids (AEA and 2AG) and serum estradiol, progesterone and cortisol concentrations.
Measured: 48 hours from dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start6 Apr 2017
- Primary completion26 Feb 2018
- Study completion26 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aelis Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michael Dobrow, MD, Principal investigator, Biotrial Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325595
- Sponsor's protocol ID
- AEF0117-101
- Other IDs
- R01DA038875
- Status last verified
- Mar 2018
- First submitted
- 11 Oct 2017
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haney M, Vallee M, Fabre S, Collins Reed S, Zanese M, Campistron G, Arout CA, Foltin RW, Cooper ZD, Kearney-Ramos T, Metna M, Justinova Z, Schindler C, Hebert-Chatelain E, Bellocchio L, Cathala A, Bari A, Serrat R, Finlay DB, Caraci F, Redon B, Martin-Garcia E, Busquets-Garcia A, Matias I, Levin FR, Felpin FX, Simon N, Cota D, Spampinato U, Maldonado R, Shaham Y, Glass M, Thomsen LL, Mengel H, Marsicano G, Monlezun S, Revest JM, Piazza PV. Signaling-specific inhibition of the CB1 receptor for cannabis use disorder: phase 1 and phase 2a randomized trials. Nat Med. 2023 Jun;29(6):1487-1499. doi: 10.1038/s41591-023-02381-w. Epub 2023 Jun 8.
PubMed 37291212
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Double-blind, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of Single Oral Doses of AEF0117 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03325595
- Acronym / sponsor ID
- AEF0117-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aelis FarmaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 26 Feb 2018 (actual)
- First posted
- 30 Oct 2017 (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 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects.
Detailed description
The overall goal of this protocol is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects. This will be a single center study in healthy adult male and female subjects. The study design will be a double-blind, randomized, placebo-controlled, single period, parallel group, single dose escalation with AEF0117.
Four dose levels are planned for the study with 8 subjects (6 active and 2 placebo, 3:1 ratio) per dose level:
Dose Level I - 0.2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level II - 0.6 mg single oral dose of AEF0117given on the morning of Day 1 Dose Level III - 2 mg single oral dose of AEF0117 given on the morning of Day 1 Dose Level IV - 6 mg single oral dose of AEF0117 given on the morning of Day 1 The planned dose escalation schema may be amended based on the emerging PK and safety data. Each subject will participate in only one dose group.
In each dosing cohort, 2 sentinel subjects (randomized 1 AEF0117: 1placebo) will be dosed and observed for safety monitoring for 24 hours prior to initiating dosing in the remaining 6 subjects (randomized 5 AEF0117: 1 placebo).
The first cohort will be administered 0.2mg. Administration of AEF0117 to the subsequent dose cohorts,0.6 mg(Cohort II), 2 mg (Cohort III), and 6 mg (Cohort IV) doses should not occur before participants in the previous dose cohort have been treated and data i.e. safety results from those participants are reviewed in accordance with the protocol.
Serial blood sample collections will be performed for 144 hours after dose administration for PK analysis, and for 48 hours after dose administration for PD analysis.
Subjects will be admitted to the research clinic at midday prior to dosing (Day -1) and remain in-house until Day 8. Randomized subjects will receive a single dose of AEF0117 on Day 1. PK samples and safety assessments will be performed pre-dose and at different times post dose. Safety monitoring (physical examinations, vital sign measurement, 12-lead electrocardiograms [ECGs], clinical safety laboratory tests, and adverse event monitoring) will be performed throughout the study. Psychometrics (Bond \& Lader VAS, ARCI, POMS) and C-SSRS tests will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: AEF0117 | Active comparator | Drug: AEF0117Subjects in Cohorts 1 through 4 receive active treatments. Subjects in Cohorts 1 through 4 will receive a single dose of 0.2, 0.6, 2 and 6mg respectively of AEF0117 on Day1. |
| Placebo Comparator: Placebo | Placebo comparator | Drug: PlaceboSubjects in Cohorts 1 through 4 will be randomly assigned in an 6:2 allocation to receive active or placebo treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be a healthy, non-smoking or smoking (<10 cigarettes per day) male of any race, at least 18 years old and no more than 55 years old, inclusive. As the effect of the study drug on sperm is still unknown, male subjects should refrain from donating sperm or plan a pregnancy with their partner throughout the study and after 90 days, and must report immediately to the study doctor if its partner becomes pregnant during the study and after 90 days. The male subject will have to use double-barrier contraceptive methods: male condoms and spermicide.
- Be a healthy, non-smoking or smoking (<10 cigarettes per day) female of non-child-bearing potential between 18 years of age and 55 years of age, inclusive. Females may be accepted if they are documented to be surgically sterile (e.g., hysterectomy, tubal ligation) or post-menopausal [amenorrhea >1 year and FSH >25.8mlU/mL, cut off from Labcorp] with a negative pregnancy test. At least 30% of female.
- Have a body weight ≥50 kg, with a body mass index (BMI) calculated as weight in kg/(height in m)2 from 18 to 30 kg/m2 (inclusive) at screening.
- Have no significant diseases in the medical history and no clinically significant findings on physical examination including ECG, BP, HR, RR, temperature, C-SSRS test. Routine laboratory values should be within normal ranges or considered as NCS by the investigator. The Non Clinical Significant nature of the deviation will result from the integration of a full clinical examination with physical examination and lab tests in that contest by a certified physician.
- Be informed of the nature of the study and provide written informed consent.
Key exclusion criteria (19 listed)
- Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients and known allergies to pregnenolone or its matching placebo or its ingredient
- Acute signs of intoxication at screening or baseline assessment due to opiates or any type of stimulants, causing cognitive impairments
- Severe learning disability, brain damage or pervasive developmental disorder ( as this may affect one of the end point that is being targeted)
- Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- Have abnormal baseline values for the steroid hormones: cortisol, testosterone, estradiol and progesterone in accordance to their reproductive status (for example but not limited to surgical sterile or post-menopausal).
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 |
|---|---|---|
| AEF01170.2, 0.6, 2, or 6mg of AEF0117 | Drug | Experimental: AEF0117 |
| PlaceboMatching capsule placebo | Drug | Placebo Comparator: Placebo |
Primary outcome
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Time frame: 168 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in vital signs
Incidence of treatment-emergent AEs and SAEs as assessed by ECGs
Time frame: 168 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in ECGs
Incidence of treatment-emergent AEs and SAEs as assessed by clinical laboratory values
Time frame: 168 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in clinical laboratory values from blood and urine samples.
Incidence of treatment-emergent AEs and SAEs as assessed by psychometric tests
Time frame: 36 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in psychometric tests (Bond and Lader VAS, ARCI, POMS) and C-SSRS test.
10 secondary outcomes
Pharmacokinetics of escalating single oral doses of AEF0117
Time frame: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Time frame: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Time frame: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Time frame: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Time frame: 144 hours from dosing
Pharmacokinetics of escalating single oral doses of AEF0117
Time frame: 144 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Time frame: 48 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Time frame: 48 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Time frame: 48 hours from dosing
Pharmacodynamics of escalating single oral doses of AEF0117
Time frame: 48 hours from dosing
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 13 Mar 2018.
- Derived from this study: PubMed 37291212Haney M, Vallee M, Fabre S, Collins Reed S, Zanese M, Campistron G, Arout CA, Foltin RW, Cooper ZD, Kearney-Ramos T, Metna M, Justinova Z, Schindler C, Hebert-Chatelain E, Bellocchio L, Cathala A, Bari A, Serrat R, Finlay DB, Caraci F, Redon B, Martin-Garcia E, Busquets-Garcia A, Matias I, Levin FR, Felpin FX, Simon N, Cota D, Spampinato U, Maldonado R, Shaham Y, Glass M, Thomsen LL, Mengel H, Marsicano G, Monlezun S, Revest JM, Piazza PV. Signaling-specific inhibition of the CB1 receptor for cannabis use disorder: phase 1 and phase 2a randomized trials. Nat Med. 2023 Jun;29(6):1487-1499. doi: 10.1038/s41591-023-02381-w. Epub 2023 Jun 8.
- Individual participant dataSharing planned: No
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Irritability
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.
Michael Dobrow, MD principal investigator
Biotrial Inc.
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 Healthy Volunteers, 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 19 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 13 Mar 2018. 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. 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?
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?
Incidence of treatment-emergent AEs and SAEs as assessed by vital signs (time frame: 168 hours from dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325595, which also lists 1 linked publication.
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 13 Mar 2018.