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NCT05147402: MPKF
Food Effects on Bioavailability of MDMA in Healthy Volunteers
Phase 1 trial testing midomafetamine in Pharmacokinetics in 14 participants. Completed in 5 December 2022.
2 December 2022
Quick facts
| Lead sponsor | Lykos Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 14 |
| Start date | 28 July 2022 |
| Primary completion | 2 December 2022 |
| Estimated completion | 5 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- midomafetamine — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Lykos Therapeutics — full company profile →
Who can join
Adults 18 to 65, any sex, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn if food impacts absorption of MDMA in participants who are either fed or fasted. The main question it aims to answer is: What is the effect of eating food on the safety of taking oral MDMA? Researchers will compare participants who are fasted for 10 hours to participants who are fed a high-fat and high-calorie meal. Participants will be randomized to either the fed or fasted group, then be administered MDMA. Vitals and blood samples will be taken. Then, participants will be assigned to the opposite condition and vitals and blood samples will be taken.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
MDMA pharmacokinetics: A population and physiologically based pharmacokinetics model-informed analysis.
Huestis MA, Smith WB, Leonowens C, Blanchard R, et al · · 2025 · cited 1× · PMID 39592887 · DOI 10.1002/psp4.13282
Verify or expand the search:
- PubMed search for NCT05147402
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Lykos Therapeutics trials
Trials by the same sponsor.
- NCT04784143 — Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD · Phase 2 · terminated
- NCT04714359 — A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD · Phase 3 · completed
- NCT05066282 — Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD · completed
- NCT04077437 — A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2) · Phase 3 · completed
- NCT03537014 — A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1) · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05147402 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lykos Therapeutics
- Last refreshed: 30 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05147402.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing