Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
← catalyst calendarNCT06500793 · readout in 125 d
Sponsored by Ensysce Biosciences (industry) · ENSC — their whole pipeline →. With Quotient Sciences, National Institute on Drug Abuse (NIDA).
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
54estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-11-24 | actual | When the study began enrolling |
| Primary completion | 2026-12-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-04-28 | estimated | The whole study's end, after follow-up |
| First posted | 2024-07-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pharmacokinetics
- Healthy Volunteer
Interventions
- Drug: PF614 capsule — also filed as PRF06104, Oxycodone prodrug
- Drug: Nafamostat Mesylate — also filed as Futhan
Primary outcomes
what the primary-completion date above is the date OFPharmacokinetic Tmax [Time to Maximum Plasma Concentration]
measured Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic Cmax [Maximum Plasma Concentration]
measured Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic C24 [Plasma concentration at 24 hours]
measured Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic AUC(0-last) [Area Under the Curve]
measured Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic AUC(0-inf) [Area Under the Curve]
measured Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic T1/2 [Half-life]
measured Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Publications
- PMID 41774070 — cited as background
- PMID 38511523 — cited as background
- PMID 28345745 — cited as background
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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