Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEnsysce Biosciences
About this trial
A single dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.
Eligibility criteria
Qualifiers
Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
Must be willing and able to comply with all study requirements.
Aged 18 to 55 years, inclusive, at time of signing informed consent.
Must agree to use an adequate method of contraception (as defined in Section 9.4).
Disqualifiers
Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease (Part 1 only: except cholecystectomy), gastrointestinal surgery (e.g. gastric bypass, gastric banding, colectomy), or neurological or psychiatric disorder, as judged by the investigator.
Trial design
Treatments tested in this trial
- PF614 capsule
- Nafamostat Mesylate
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ensysce Biosciences
Lead sponsor
Quotient Sciences
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov