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New treatment option for Pharmacokinetics
Official title Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
ClinicalTrials.gov ID: NCT06500793
What this study is testing
What is PF614 capsule?
PF614 capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pharmacokinetics.
Also referred to as PRF06104, Oxycodone prodrug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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)...
- people with a history of seizures.
- people with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.
See the full eligibility 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.
- 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...
- people with a history of seizures.
- people with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.
- people with a history of bleeding disorders or coagulopathy.
- people 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).
- Parts 2 and 3 only: people with a history of cholecystectomy or gall stones.
- Parts 2 and 3 only: people with a history of opioid intolerance or hypersensitivity based on previous experience receiving any opioid analgesic
- Have poor venous access that limits phlebotomy.
- Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). people with Gilbert's Syndrome are allowed.
- people with a platelet count \ 1.1 at screening.
- people with hemoglobin \<LLN at screening and/or first admission.
- people with a QT interval corrected using Fridericia's formula (QTcF) above 450 msec at screening and/or first admission.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- Positive serum pregnancy test at screening or first admission. Those who are pregnant or lactating will be excluded.
- people who have received any IMP in a clinical research study within 5 half lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30...
- people who have previously been administered IMP in this study.
- people who are taking, or have taken, any prescribed or over the counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or hormonal contraception) in the 14 days before study treatment...
- people with an anticipated need for requiring aspirin, non-steroidal anti-inflammatory drugs, or anticoagulants in the 14 days after administration of the IMP.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine).
- A confirmed positive alcohol urine test at screening or first admission.
- Current smokers and those who have smoked within the last 12 months.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- A confirmed positive urine cotinine test at screening or first admission.
- Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1).
- Male people with pregnant or lactating partners.
- Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study treatment.
- people who are, or are immediate family members of, a study site or sponsor employee.
- Failure to satisfy the investigator of fitness to participate for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.