Evaluation of Oral PF614 Relative to OxyContin
2022年9月16日 更新者：Ensysce Biosciences
A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects
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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (実際)
84
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Utah
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Salt Lake City、Utah、アメリカ、84124
- PRA Health Sciences-Early Development Services
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～50年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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PF614はオキシコドンプロドラッグです
他の名前：
Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers
他の名前：
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アクティブコンパレータ：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 |
PF614はオキシコドンプロドラッグです
他の名前：
Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers
他の名前：
Bioequivalence single-dose comparison to OxyContin
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
時間枠：30 days
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Adverse Events, Significant Adverse Events, Adverse Events leading to discontinuation
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30 days
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Pharmacokinetics AUC [Area Under the Curve]
時間枠：Full PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Area under the concentration-time curve from the time of dosing to the start of the next dosing interval using PF614 concentrations and oxycodone concentrations in plasma.
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Full PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Cmax [Maximum Plasma Concentration]
時間枠：PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Maximum (peak) plasma concentration first dose
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PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Tlag [Time to first measurable plasma concentration]
時間枠：PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Time prior to the time corresponding to the first measurable (non-zero) concentration
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PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Tmax [Time to maximum plasma concentration]
時間枠：PK sampling time points 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Time to maximum plasma concentration on Day 1 (first dose)
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PK sampling time points 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics AUC, Steady State
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Steady-state (Day 5) area under the concentration-time curve from the time of dosing extrapolated to time infinity
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics CL/F [Clearance]
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Apparent total systemic clearance
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Cmax, Steady State
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Maximum (peak) plasma concentration at steady-state on Day 5
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Tmax, Steady State
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Time to maximum plasma concentration on Day 5
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics t1/2 [Half-life]
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Terminal elimination half-life
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Vz/F [Volume of Distribution]
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Apparent volume of distribution during the terminal-elimination phase
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics elimination rate
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Terminal elimination rate/constant
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Ctrough [Minimum Plasma Concentration before next dose]
時間枠：Prior to dosing on Days 2, 3, and 4
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Concentrations prior to dosing
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Prior to dosing on Days 2, 3, and 4
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Pharmacokinetics Part B AUC
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Area under the concentration-time curve from the time of dosing extrapolated to time infinity in fed vs fasted state
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B AUC 0-t
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Area under the concentration-time curve from the time of dosing to the last measurable concentration in fed vs fasted state
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B Cmax
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Maximum (peak) plasma concentration in fed vs fasted state
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Bioavailability and Bioequivalence
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Bioavailability and Bioequivalence of single oral doses of PF614 prodrug and oxycodone derived from from PF614 vs. oxycodone derived from OxyContin in healthy adult subjects (Part B)
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pharmacokinetics Part B CL/F
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Apparent total systemic clearance
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B pAUC
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Partial area under the concentration-time curve from the time of dosing to 12 hours post dose
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B Tlag
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Time prior to the time corresponding to the first measurable dose (non-zero) concentration
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B Tmax
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Time to maximum plasma concentration on Day 1 (first dose)
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B t1/2
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Terminal elimination half life
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B Vz/F
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Apparent volume of distribution during the terminal elimination phase
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Pharmacokinetics Part B Terminal elimination rate
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Terminal elimination rate constant
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Plasma Concentration of inactive metabolic fragment #1
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Evaluate plasma concentrations of PFR06082 (Part A only)
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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Plasma Concentration of inactive metabolic fragment #2
時間枠：PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
|
Evaluate plasma concentrations of PFR06110 (Part A only)
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PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：William K Schmidt, PhD、Chief Medical Officer, Ensysce Biosciences
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年9月8日
一次修了 (実際)
2022年3月21日
研究の完了 (実際)
2022年3月21日
試験登録日
最初に提出
2021年9月2日
QC基準を満たした最初の提出物
2021年9月9日
最初の投稿 (実際)
2021年9月14日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月19日
QC基準を満たした最後の更新が送信されました
2022年9月16日
最終確認日
2022年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
PF614の臨床試験
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Ensysce BiosciencesDr. Vince Clinical Research完了
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Ensysce BiosciencesNational Institute on Drug Abuse (NIDA); Quotient Sciences完了