Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395688
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Drug-Drug Interaction Between THC and AEF0117
Sponsor:
Aelis Farma
Organization:
Aelis Farma
Study Overview
Official Title:
A Double Blind Placebo-controlled Trial in Healthy Volunteers to Investigate the Effect of Multiple Oral Doses of AEF0117 Versus Placebo on the Pharmacokinetics of THC and Its Metabolites 11 OH THC and THC COOH When Smoking Cannabis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DDI
Brief Summary:
This trial is a single center double blind placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis
Detailed Description:
The goal of this clinical trial is to investigate if AEF0117 has any effect on the pharmacokinetics of THC and its metabolites when smoking cannabis
Participants will be male or female in good health aged from 21y to 55y old and who are recreational cannabis users
The participant will receive either AEF0117 2 mg or placebo The sponsor team the research staff and the participant wont know which study medication has been given
The main objectives of the trial are
To compare the effect of AEF0117 multiple doses on the maximal plasma concentration and other pharmacokinetic parameters of the THC and its metabolites
To investigate safety and tolerability of multiple doses of AEF0117 and when co-administered with a dose of smoked cannabis
The participant will come for 2 inpatient phases including one overnight stay Those 2 inpatient phases are separated by 5 days at home
After a screening period assessing the good health and the eligibility of the participant on day 1 they will receive 2 capsules of the study medication and will smoke one cannabis cigarette During the day blood samples will be collected at defined timepoints before the study medication after the study medication and before smoking and after smoking
On day 2 Blood samples will be collected before and after the study medication intake
At the end of the assessements the participant will be discharged They could be requested to stay at the research facility if they experience any adverse effects From Day 3 to Day 7 the participant will be contacted by phone or by videoconference to confirm the study medication intake and if they experience any adverse events
On day 8 the participant will come back to the research facility for a 2 days visit including an overnight stay Assessments and procedures will similar to those performed on Day 1 and Day 2
On Day 14 the participant will come back to the research facility a last time for a final blood collection
Participants will be male or female in good health aged from 21y to 55y old and who are recreational cannabis users
The participant will receive either AEF0117 2 mg or placebo The sponsor team the research staff and the participant wont know which study medication has been given
The main objectives of the trial are
To compare the effect of AEF0117 multiple doses on the maximal plasma concentration and other pharmacokinetic parameters of the THC and its metabolites
To investigate safety and tolerability of multiple doses of AEF0117 and when co-administered with a dose of smoked cannabis
The participant will come for 2 inpatient phases including one overnight stay Those 2 inpatient phases are separated by 5 days at home
After a screening period assessing the good health and the eligibility of the participant on day 1 they will receive 2 capsules of the study medication and will smoke one cannabis cigarette During the day blood samples will be collected at defined timepoints before the study medication after the study medication and before smoking and after smoking
On day 2 Blood samples will be collected before and after the study medication intake
At the end of the assessements the participant will be discharged They could be requested to stay at the research facility if they experience any adverse effects From Day 3 to Day 7 the participant will be contacted by phone or by videoconference to confirm the study medication intake and if they experience any adverse events
On day 8 the participant will come back to the research facility for a 2 days visit including an overnight stay Assessments and procedures will similar to those performed on Day 1 and Day 2
On Day 14 the participant will come back to the research facility a last time for a final blood collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DA053832 | NIH | None | httpsreporternihgovquickSearchU01DA053832 |