Evaluation of Oral PF614 Relative to OxyContin

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ensysce Biosciences
• Collaborator: PRA Health Sciences
• Treatments: Naltrexone; Oxycodone

Criteria

Inclusion Criteria:

• Males or females, ages 18-50 years in good general health,

• BMI between 18 and 32 kg/m (inclusive)

• Subjects must have a negative screen for drugs of abuse, nicotine, alcohol, Hepatitis B, Hepatitis C, and HIV.

• Female subjects of child bearing potential must have a negative serum pregnancy test at randomization

• Females must be of non-child bearing potential (e.g. postmenopausal) or of childbearing potential and agree to use a highly effective form of contraception from the time of screening to two weeks after last dose of study medication.

• Subjects must have normal findings in a physical examination and 12 lead ECG and normal Vital Signs

• Clinical laboratory values must be Within Normal limits as defined by the clinical laboratory

• Subjects must be able to provide coherent written informed consent

• Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.

Exclusion Criteria:

• History of allergy or sensitivity to oxycodone

• History of loud snoring or sleep apnea

• History of medical problems encountered with opioid therapy

• Urinary cotinine levels indicative of smoking or history of smoking or regular tobacco use with 2 months prior to screening

• History of alcoholism or drug abuse

• Use of prescription medications within 14 days of study drug administration with exception of contraceptives used by female subjects

• Use of any opioid within 30 days prior to screening

• History of allergy or sensitivity to naltrexone

• History of allergy or sensitivity to naloxone

• Donation of blood within 30 days prior to screening

• Donation of plasma within 30 days prior to screening

• Acute illness at admission of clinical study unit

• History of GI disturbance requiring use of antacid twice weekly or more

• Females who are breastfeeding

• Anticipated need for surgery or hospitalization during the study

• Enrollment in an investigational drug study within 30 days prior to screening

• Any condition that in the Investigator's opinion puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.