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HealthyPhase 1SADNCT02454712

Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)

A Phase 1 study testing PF614, Oxycodone extended-release and Naltrexone Hydrochloride in people with Healthy, run by Ensysce Biosciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF614, Oxycodone extended-release and Naltrexone Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
16 Nov 2016to 18 Jan 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males and females, ages 18-50 years (inclusive) in good general health;
  • Body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive);
  • Minimum weight of 50.0 kg, inclusive;
  • 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;
  • Female subjects must have a negative serum pregnancy test at screening and a negative pregnancy test on Day -1;
  • 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;
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  • Male subjects must agree not to donate sperm throughout the study and for 90 days after the last study drug administration;
  • 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;
  • 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;
  • Subjects must be able to provide meaningful written informed consent;
  • Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.

Who cannot join

  • History of allergy or sensitivity to oxycodone, OxyContin, any other opiate, naltrexone, or naloxone;
  • History of loud snoring or sleep apnea;
  • History of medical problems encountered with opioid therapy;
  • Urinary cotinine levels indicative of smoking or history of regular use of tobacco-containing or nicotine-containing products within 2 months prior to screening;
  • History of alcoholism or drug abuse (prescription or illicit drugs) according to Diagnostic and Statistical Manual IV-Text Revision (DSM IV-TR) criteria;
  • 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;
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  • Use of any opioid within 30 days prior to screening;
  • Donation of blood within 60 days prior to screening;
  • Donation of plasma, platelets, or white blood cells within 7 days prior to dosing;
  • Acute illness (eg, gastrointestinal illness, infection such as influenza, upper respiratory tract infection, or known inflammatory process) within 7 days of dosing
  • History of gastrointestinal disturbance requiring frequent use of antacid;
  • 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);
  • Anticipated need for surgery or hospitalization during the study or follow-up period;
  • 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;
  • Women who are lactating;
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PRA Health Sciences - Early Development Services

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Dose-Escalation Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of PF614 in Healthy Subjects Compared to OxyContin®

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.

Read the detailed description

This will be a Phase 1 randomized, single-center, SAD study in 6 cohorts of 8 healthy male and/or female subjects each (Cohorts 1-6) plus 16 enrolled healthy male and/or female subjects (Cohort 7). The study will evaluate the safety and PK of PF614 and the PK of oxycodone at doses sufficient to characterize the extent to which plasma oxycodone is produced and maintained following oral ingestion of PF614. The PK of the prodrug fragments will also be evaluated. There will be a parallel study arm in each cohort dosed that will use oral OxyContin® as an active comparator. Subjects will receive PF614 (n=6) or OxyContin as comparator (n=2) orally in the fasted state. In addition, all subjects starting with Cohort 1C will receive naltrexone at 14 hours pre-dose, 2 hours pre-dose and 10 hours post dose to block the effects of oxycodone. The starting dose for administration of PF614 will be 15 mg. The lowest available dose of OxyContin, 10 mg, will be used as the comparator in the first cohort. PK assessments will be conducted after each cohort to compare the oxycodone area under curve (AUC) of PF614 and OxyContin to determine the most appropriate dose for the subsequent cohorts. In Cohort 6 (fed subjects), all subjects (n=8) will receive the same PF614 and naltrexone doses as administered in Cohort 5 to evaluate the PK and safety of PF614 in fed vs. fasted state. Subjects in Cohort 6 will receive a Food and Drug Administration-defined high-fat, high-calorie breakfast 30 minutes prior to study drug administration. In Cohort 7, treatments will be administered in a cross-over study design across 2 periods. All subjects (n=16 enrolled; estimated n=12 completers) will receive the same PF614 dose as administered in Cohort 1 (15 mg) with and without naltrexone to evaluate the potential effect of naltrexone on the plasma PK of PF614 and oxycodone. Cohort 7, Period 1 subjects may return for their cross-over treatments in Period 2 after a minimum of 12 days after receiving their initial Cohort 7 doses.

Conditions
Healthy
Being tested
PF614, Oxycodone extended-release, Naltrexone Hydrochloride
Keywords
Prodrug, PF614, oxycodone extended-release, oral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF614Drug

    Also called PRF06104

    PF614 is an oxycodone prodrug

  • Oxycodone extended-releaseDrug

    Also called OxyContin

    Oxycodone extended-release is the comparator drug

  • Naltrexone HydrochlorideDrug

    Also called ReVia

    Naltrexone HCl tablets, 50 mg, will be used to block high dose opioid effects in healthy volunteers

Study groups in NCT02454712
Study groupRoleWhat they receive
PF614ExperimentalPF614 is the drug under evaluation. Doses may range from 15 mg to 640 mg. N=6 subjects per cohort. For Cohort 7, N=16 subjects in crossover study ± naltrexone.
Receives: Drug: PF614; Drug: Naltrexone Hydrochloride
Oxycodone extended-release (OxyContin)Active comparatorInitial dose (Cohort 1) will be 10 mg. Subsequent doses will be 10, 20, 40, or 80 mg. N=2 subjects per cohort. Active comparator will not be used in Cohort 7.
Receives: Drug: Oxycodone extended-release; Drug: Naltrexone Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Adverse events

    Measured: 30 days

Secondary outcomes (9)

  1. Pharmacokinetics (Cmax)

    Peak plasma concentrations of oxycodone derived from PF614 and OxyContin

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  2. Pharmacokinetics (Tmax)

    Time to peak plasma concentrations of oxycodone derived from PF614 and OxyContin

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  3. Pharmacokinetics (AUC)

    Area under the plasma concentration vs. time curve (AUC) for oxycodone derived from PF614 and OxyContin

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  4. Dose Selection (Identify doses of PF614 with pharmacokinetics comparable to OxyContin)

    Identify doses of PF614 with pharmacokinetics comparable to OxyContin

    Measured: 4 days

  5. Prodrug Fragments (plasma concentration)

    Evaluate appearance and plasma concentrations of metabolic fragments derived from PF614

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  6. Pharmacokinetics (Cmax) in fed vs. fasted state

    Peak plasma concentrations of oxycodone derived from PF614

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  7. Pharmacokinetics (Tmax) in fed vs. fasted state

    Time to peak plasma concentrations of oxycodone derived from PF614

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  8. Pharmacokinetics (AUC) in fed vs. fasted state

    Area under the plasma concentration vs. time curve (AUC) for oxycodone derived from PF614

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

  9. Effect of naltrexone on PF614 and oxycodone plasma PK in a crossover design

    Cmax and AUC of plasma oxycodone

    Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2015 (estimated)
  2. Study start16 Nov 2016
  3. Primary completion18 Jan 2018
  4. Study completion18 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02454712
Sponsor's protocol ID
PF614-101
Acronym
SAD
Status last verified
Sep 2024
First submitted
12 May 2015
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kirkpatrick DL, Evans C, Pestano LA, Millard J, Johnston M, Mick E, Schmidt WK. Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers. Clin Transl Sci. 2024 Mar;17(3):e13765. doi: 10.1111/cts.13765.

    PubMed 38511523

  • Schmidt WK, Dickerson DS, Fisher DM, Kirkpatrick DL. First-in-human pharmacokinetics & safety study of PF614: orally activated oxycodone prodrug. Anesth Analg. 2017;124(5):752-753.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF614, Oxycodone extended-release and Naltrexone Hydrochloride in people with Healthy, run by Ensysce Biosciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02454712, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.

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