5 completed, 1 terminated, 1 withdrawn. 7 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 5, Terminated 1, Withdrawn 1 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Drug-Drug Interaction Between THC and AEF0117 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one, Placebo - Cannabis Abuse | Phase 1 | Withdrawn | Aelis Farma | 2025-12-01 | 2026-02-27 | |
| The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition, 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition - Marijuana Abuse | Phase 1 | Terminated | Aelis Farma | 22 | 2023-01-04 | 2026-01-22 |
| Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects AEF0117 - Marijuana Abuse | Phase 1 | Completed | Aelis Farma | 8 | 2022-12-16 | 2023-04-07 |
| Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome Placebo, AEF0217 - Down Syndrome | Phase 1 / Phase 2 | Completed | Aelis Farma | 40 | 2022-12-15 | 2024-10-10 |
| AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects. AEF0217, Placebo - Safety, Tolerability, Pharmacokinetics of AEF0217 | Phase 1 | Completed | Aelis Farma | 68 | 2021-10-01 | 2024-02-01 |
| Multiple Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117 AEF0117 oral capsule, Placebo oral capsule - Healthy Volunteers | Phase 1 | Completed | Aelis Farma | 24 | 2018-01-08 | 2018-06-19 |
| Single Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117 AEF0117, Placebo - Healthy Volunteers | Phase 1 | Completed | Aelis Farma | 40 | 2017-04-06 | 2018-03-13 |
Marijuana Abuse (3) · Down Syndrome (1)
United States (4) · Spain (2)
Margaret Haney, PhD (2) · Michael Dobrow, MD (2) · Irene Mirkin, MD (1)
R01DA038875 (2), U01DA053832 (2)