A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants
2026年6月1日 更新者:Incyte Corporation
An Open-Label, Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants
The purpose of this study is to evaluate the interstitial concentrations using the open-flow microperfusion device and plasma pharmacokinetics following multiple doses of povorcitinib or topical ruxolitinib cream in healthy adult participants.
調査の概要
研究の種類
介入
入学 (推定)
24
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。
研究連絡先
- 名前:Incyte Corporation Call Center (US)
- 電話番号:1.855.463.3463
- メール:medinfo@incyte.com
研究連絡先のバックアップ
- 名前:Incyte Corporation Call Center (ex-US)
- 電話番号:+800 00027423
- メール:eumedinfo@incyte.com
研究場所
-
-
Minnesota
-
Dilworth、Minnesota、アメリカ、56529
- 募集
- Axis Clinicals
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 18 to 65 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 30.5 kg/m2, inclusive.
- No clinically significant findings on screening evaluations (clinical, laboratory, and ECG).
- Ability to swallow and retain oral medication.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- Participants with any history of an autoimmune disease diagnosis.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
- History or presence of an abnormal ECG.
- Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
- Any malignancies or history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy; excluding appendectomy and hernia repair) that could affect the absorption of study drug.
- Any major surgery within 4 weeks of screening.
- Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma-only donation).
- Blood transfusion within 4 months of check-in (Day -1).
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes latent treated tuberculosis).
- Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
- Has received a live vaccine (including attenuated) or anticipation of need for such a vaccine during the study within 3 months prior to the first dose of study drug. Note: Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, chickenpox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.
- Medical or self-reported history of alcoholism within 3 months of screening.
- History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females (1 unit = 8 oz of beer or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type).
- Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study treatment with another investigational medication or current enrollment in another investigational drug study.
- Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose/application of study treatment with strong inducers or strong and moderate inhibitors of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database for prohibited drugs.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to povorcitinib or any excipients of povorcitinib, to ruxolitinib or any excipients of ruxolitinib or any JAK inhibitors.
- Inability to undergo venipuncture or tolerate venous access.
- History of tobacco or nicotine containing product use within 1 month of screening.
- Use of prescription drugs (including hormonal contraceptives) within 14 days of study treatment administration/application or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days before study treatment administration/application. However, occasional and standard dose paracetamol, acetaminophen, ibuprofen, and standard dose vitamins are permitted. Mega dose vitamins or supplements are not permissible.
- Women who are pregnant or breastfeeding.
- Any condition that would interfere with full participation in the study, including administration/application of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- Excessive exercise (ie Iron man®, triathlon, etc) within 7 days before check-in (Day -1).
- Tattoo or scarring at skin sample sites.
- Participants prone to keloid or hypertrophic scar formation or any known wound healing disorder.
- Not willing to avoid excessive sun exposure, steam baths, sauna, swimming, and other strenuous activities for 14 days after Day 12 to ensure good tissue regeneration.
- Pronounced hairiness on the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, that may negatively affect dose application, probe placement, and/or sample testing.
- Not willing to refrain from shaving the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, or using skin care products on the planned application sites, dOFM probe insertion sites, and skin biopsy collection sites, for at least 5 days before Day 1.
- Not willing to avoid sunbathing, using tanning salons, or using spray/lotion tanning agents within 7 days prior to Day 1 dose administration/application.
- Presence of needle phobia.
- Increased risk of thrombosis (eg, personal or first-degree relative[s] history of deep vein thrombosis).
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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:非ランダム化
- 介入モデル:並列代入
- 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 |
|---|---|
|
実験的:Cohort 1: Ruxolitinib 1.5 % Cream
Ruxolitinib cream applied topically twice daily.
|
Ruxolitinib cream applied topically.
|
|
実験的:Cohort 2: Povorcitinib
Povorcitinib will be administered at the protocol defined dose.
|
オーラル;タブレット
他の名前:
|
|
実験的:Cohort 3: Povorcitinib
Povorcitinib will be administered at the protocol defined dose.
|
オーラル;タブレット
他の名前:
|
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 |
|---|---|---|
|
Pharmacokinetics Parameter (PK): Cmax of dermal interstitial fluid (dISF) ruxolitinib
時間枠:Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of dISF ruxolitinib
時間枠:Up to Day 12
|
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUC∞ of dISF ruxolitinib
時間枠:Up to Day 12
|
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Cmax of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUC∞ of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Cmax of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUC∞ of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Cmax of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the maximum observed plasma concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUClast of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the area under the concentration-time curve from time zero to the last quantifiable concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: AUC∞ of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the area under the plasma concentration-time curve extrapolated to time of infinity.
|
Up to Day 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with Treatment-emergent Adverse Events (TEAEs)
時間枠:Up to Day 28
|
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment.
|
Up to Day 28
|
|
Pharmacokinetics Parameter: tmax of dISF ruxolitinib
時間枠:Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of dISF ruxolitinib
時間枠:Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of dISF ruxolitinib
時間枠:Up to Day 12
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Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of dISF ruxolitinib
時間枠:Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of dISF ruxolitinib
時間枠:Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: tmax of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of dISF povorcitinib
時間枠:Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: tmax of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of plasma ruxolitinib
時間枠:Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: tmax of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the time to maximum concentration.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: t½ of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the apparent terminal-phase disposition half-life.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: CL/F of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the apparent clearance.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: Vz/F of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the apparent volume of distribution.
|
Up to Day 12
|
|
Pharmacokinetics Parameter: λz of plasma povorcitinib
時間枠:Up to Day 12
|
Defined as the terminal-phase disposition rate constant.
|
Up to Day 12
|
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:Incyte Medical Monitor、Incyte Corporation
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)
2026年5月18日
一次修了 (推定)
2026年9月3日
研究の完了 (推定)
2026年9月19日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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。