Overview

Study of PF614 Compared to OxyContin® in Healthy Volunteers

Status:
Completed

Trial end date:
2018-01-10

Target enrollment:
0

Participant gender:
All

Summary

PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Ensysce Biosciences

Collaborator:

PRA Health Sciences

Treatments:

Naltrexone
Oxycodone

Criteria

Inclusion Criteria:

1. Males and females, ages 18-50 years (inclusive) in good general health;

2. Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive);

3. Minimum weight of 50.0 kg, inclusive;

4. Subjects must have a negative screen for drugs of abuse, cotinine, alcohol, hepatitis
B-surface antigen, hepatitis C antibody and antibodies against HIV 1 and 2;

5. Female subjects must have a negative serum pregnancy test at screening and a negative
pregnancy test on Day -1;

6. Females of childbearing potential and males and their female partner(s) of
childbearing potential must agree to use 2 forms of contraception, 1 of which must be
a barrier method, during the study and for 90 days after the last drug administration.
Acceptable barrier forms of contraception are condom and diaphragm. Acceptable
nonbarrier forms of contraception for this study are a nonhormonal intrauterine device
(IUD), oral contraceptives and/or spermicide;

7. Male subjects must agree not to donate sperm throughout the study and for 90 days
after the last study drug administration;

8. Subjects must have normal or no evidence of clinically significant findings in
physical examination and 12-lead electrocardiogram (ECG) according to the
Investigator, and normal vital signs (respiratory rate between 10 and 18 breaths per
minute, blood pressure between 100-139/50-89 mmHg, heart rate between 40-100 beats per
minute, temperature between 96.44°F and 100.04°F (between 35.8°C and 37.8°C), and
oxygen saturation (SpO2) > 97% in the absence of supplemental oxygen;

9. Clinical laboratory values must be within the normal limits as defined by the clinical
laboratory, unless the Investigator decides that out-of-range values are not
clinically significant;

10. Subjects must be able to provide meaningful written informed consent;

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

Exclusion Criteria:

1. History of allergy or sensitivity to oxycodone, OxyContin, any other opiate,
naltrexone, or naloxone;

2. History of loud snoring or sleep apnea;

3. History of medical problems encountered with opioid therapy;

4. Urinary cotinine levels indicative of smoking or history of regular use of
tobacco-containing or nicotine-containing products within 2 months prior to screening;

5. History of alcoholism or drug abuse (prescription or illicit drugs) according to
Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR) criteria;

6. Use of prescription medications within 14 days of study drug administration, except
for contraceptive medications used by female subjects; use of over-the-counter (OTC)
medications within 7 days prior to study drug administration;

7. Use of any opioid within 30 days prior to screening;

8. Donation of blood within 60 days prior to screening;

9. Donation of plasma, platelets, or white blood cells within 7 days prior to dosing;

10. Acute illness (eg, gastrointestinal illness, infection such as influenza, upper
respiratory tract infection, or known inflammatory process) within 7 days of dosing

11. History of gastrointestinal disturbance requiring frequent use of antacid;

12. History of clinically significant gastrointestinal disease and/or surgery which would
result in the subject's inability to absorb or metabolize the study drug (eg,
gastrectomy, gastric bypass, cholecystectomy);

13. Anticipated need for surgery or hospitalization during the study or follow-up period;

14. Dosing with an investigational drug or participation in an investigation device study
within 30 days or 5 half-lives of first dose of the study drug;

15. Women who are lactating;

16. Any other condition, that, in the Investigator's opinion, (i) puts the subject at
increased risk, (ii) could confound the study results (iii) may interfere
significantly with the subject's participation in the study or (IV) has the potential
to limit the subject's ability to complete the study.