Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. 2. Must be willing and able to comply with all study requirements. 3. Aged 18 to 55 years, inclusive, at time of signing informed consent. 4. Must agree to use an adequate method of contraception (as defined in Section 9.4). 5. Healthy males or non pregnant, non lactating healthy females. 6. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator. 7. Minimum weight of 50 kg at screening. Exclusion Criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients. 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. 3. Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria. 4. H