Evaluation of Oral PF614 Relative to OxyContin (PF614-102)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-08

Study Completion Date

2022-03-21

Brief Summary

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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.

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Detailed Description

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This study is intended to evaluate the pharmacokinetics of OxyContin (oxycodone ER) and PF614, as well as PF614 fragments, following administration of multiple ascending doses of PF614, and to compare to steady-state pharmacokinetics to those of OxyContin. (Part A)

In addition, oral bioavailability of oxycodone derived from single doses of PF614 of the to-be-marketed capsule formulation will be compared to that of the reference drug, OxyContin, in the fasted and fed condition. A pivotal food effect assessment will be incorporated into the study to determine the impact of a high fat meal on the bioavailability of oxycodone, following oral single-dose administration of PF614 (Part B).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Part A will utilize a randomized, open label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects per group.

Part B will utilize an open-label, single-dose, randomized, 4-way crossover design with 13 subjects in each treatment sequence.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF614

Part A will utilize a randomized, open-label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects. Within each dose group, subjects will be randomized to receive repeated BID doses, planned to be 12 hours apart over a 5 day period, for a total of 9 doses. Dose escalation to Dose Groups 2 and 3 will follow a review of pharmacokinetic, safety and tolerability data up to Day 10 of the preceding group. The doses or dosing regimen for Dose groups 2 and 3 may be modified based on a review of the data.

Group Type EXPERIMENTAL

PF614

Intervention Type DRUG

PF614 is an oxycodone prodrug

Naltrexone Hydrochloride

Intervention Type DRUG

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

Part B Compare Bioavailability and Bioequivalence

Part B will utilize an open-label, single-dose, randomized, 4-way crossover design. Following confirmation of eligibility, subjects will be randomized to receive each of the single oral doses of study drugs (one at each treatment period).

PF614 100 mg administered under fasted conditions; PF614 100 mg administered under fed conditions; OxyContin 40 mg administered under fasted conditions; OxyContin 40 mg administered under fed conditions

Group Type ACTIVE_COMPARATOR

PF614

Intervention Type DRUG

PF614 is an oxycodone prodrug

Naltrexone Hydrochloride

Intervention Type DRUG

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

OxyContin

Intervention Type DRUG

Bioequivalence single-dose comparison to OxyContin

Interventions

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PF614

PF614 is an oxycodone prodrug

Intervention Type DRUG

Naltrexone Hydrochloride

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

Intervention Type DRUG

OxyContin

Bioequivalence single-dose comparison to OxyContin

Intervention Type DRUG

Other Intervention Names

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oxycodone prodrug ReVia OxyContin 40 mg Extended-Release Tablet

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes