Miami, FLNCT06500793Now EnrollingIRB Ready

Pharmacokinetics Clinical Trial in Miami, FL

Access cutting-edge pharmacokinetics treatment through this clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by Ensysce Biosciences

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Expert Care in Miami

Access pharmacokinetics specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pharmacokinetics treatment provided free

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Check if you qualify for this pharmacokinetics clinical trial in Miami, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Pharmacokinetics Study in Miami

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.

Sponsor: Ensysce Biosciences

Who Can Participate

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.
Subjects with a history of seizures.
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).
Parts 2 and 3 only: Subjects with a history of cholecystectomy or gall stones.
Parts 2 and 3 only: Subjects 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). Subjects with Gilbert's Syndrome are allowed.
Subjects with a platelet count \<150,000/µL or international normalized ratio \>1.1 at screening.
Subjects with hemoglobin \<LLN at screening and/or first admission.
Subjects 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.
Subjects 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 days.
Subjects who have previously been administered IMP in this study.
Subjects 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 administration (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
Subjects 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 subjects 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.
Subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT06500793) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pharmacokinetics Treatment Options in Miami, FL

If you're searching for pharmacokinetics treatment options in Miami, FL, this clinical trial (NCT06500793) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pharmacokinetics specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pharmacokinetics clinical trials near you to find additional studies recruiting in your area.

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