Study of PF614 and Nafamostat for Oxycodone Pharmacokinetics
This study is looking at how your body handles PF614 (an oxycodone prodrug) when it's given alone and with Nafamostat Mesylate. Researchers want to understand how these drugs are absorbed, distributed, and eliminated from your body (pharmacokinetics). They are particularly interested in how Nafamostat affects the release of oxycodone from PF614. You can join if you are a healthy volunteer between 18 and 55 years old. The study aims to measure the maximum amount of the drug in your blood (Cmax) and how long it takes to reach that maximum (Tmax) at different time points over 72 hours. The current recruitment status is unclear.
- Study design
- This is a single-dose interventional study planning to enroll 54 healthy volunteers.
- What's involved
- You will receive single doses of PF614 capsules and/or Nafamostat Mesylate. Blood samples will be taken at various times over 72 hours to measure drug levels.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your drug levels will be measured for up to 72 hours after receiving the study medication.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jeffrey Levy, MD, PhD · PRINCIPAL_INVESTIGATOR · Medical Director, Quotient Sciences
Who to contact
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What this trial measures
- Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Time to maximum observed concentrations of oxycodone following administration of PF614 alone and with nafamostat
- Pharmacokinetic Cmax [Maximum Plasma Concentration]Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Maximum (peak) observed concentration of oxycodone following administration of PF614 alone and with nafamostat
- Pharmacokinetic C24 [Plasma concentration at 24 hours]Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Concentration of oxycodone at 24 hours post-dose following administration of PF614 alone and with nafamostat
- Pharmacokinetic AUC(0-last) [Area Under the Curve]Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Area under the concentration-time curve from time 0 to the time of last measurable concentrations of oxycodone following administration of PF614 alone and with nafamostat
- Pharmacokinetic AUC(0-inf) [Area Under the Curve]Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Area under the concentration-time curve from time 0 extrapolated to time-infinity of oxycodone following administration of PF614 alone and with nafamostat
- Pharmacokinetic T1/2 [Half-life]Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Terminal elimination half-life concentrations of oxycodone following administration of PF614 alone and with nafamostat