Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614… (NCT06500793) | Clinical Trial Compass
RecruitingPhase 1
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
United States30 participantsStarted 2024-11-24
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Healthy males or non pregnant, non lactating healthy females.
✓. 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.
✓. Minimum weight of 50 kg at screening.
Exclusion criteria
✕. 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.
What they're measuring
1
Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]
✕. Subjects with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.
✕. Subjects with a history of bleeding disorders or coagulopathy.
✕. Subjects with any personal history of arrhythmias or family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction prior to 50 years old).