A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS
2020年5月18日 更新者:Pfizer
A PHASE I, OPEN LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE STEADY STATE PHARMACOKINETIC DRUG-DRUG INTERACTION BETWEEN PF-06650833 AND PF-06651600 IN HEALTHY ADULT PARTICIPANTS
The purpose of this study is to evaluate the potential pharmacokinetic (PK) drug-drug interaction (DDI) between PF-06650833 and PF-06651600 in healthy adult participants.
調査の概要
研究の種類
介入
入学 (実際)
15
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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Connecticut
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New Haven、Connecticut、アメリカ、06511
- Pfizer New Haven Clinical Research Unit
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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~55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:
- Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD)
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, temperature, 12-lead ECG, and laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
- Infection with hepatitis B or hepatitis C viruses according to protocol-specific testing algorithm.
- Participants with any of the protocol-listed acute or chronic infections or infection history.
- History of febrile illness within 5 days prior to the first dose of investigational product (in both Periods).
- History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- Participants have a known present or a history of malignancy other than a successfully treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Benign ethnic (cyclic) neutropenia.
- Having received any live (attenuated) vaccines within 6 weeks prior to the first dose of investigational product.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
- Previous administration of an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of investigational product used in this study.
- Known participation in a clinical trial of PF-06650833 or PF-06651600.
- A positive urine drug test at screening or admission.
- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- Participants with any of the protocol-listed abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary.
- Have evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
- Have a history of major organ transplant or hematopoietic stem cell/marrow transplant. Skin grafts are allowed.
- Systemic therapy with any of the medications that are CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer) or CYP3A4 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of the trial medication.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Considerations criteria of the protocol.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of 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:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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:Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
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In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.
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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 |
|---|---|---|
|
PF-06650833 Cmax
時間枠:Fold-change from Period 1/Day 5 to Period 2/Day 12
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Maximum observed concentration (Cmax) derived from plasma
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Fold-change from Period 1/Day 5 to Period 2/Day 12
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PF-06650833 AUCtau
時間枠:Fold-change from Period 1/Day 5 to Period 2/Day 12
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Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
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Fold-change from Period 1/Day 5 to Period 2/Day 12
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PF-06651600 Cmax
時間枠:Fold-change from Period 2/Day 7 to Period 2/Day 12
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Maximum observed concentration (Cmax) derived from plasma
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Fold-change from Period 2/Day 7 to Period 2/Day 12
|
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PF-06651600 AUCtau
時間枠:Fold-change from Period 2/Day 7 to Period 2/Day 12
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Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
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Fold-change from Period 2/Day 7 to Period 2/Day 12
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Percentage of participants with treatment emergent adverse events
時間枠:From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
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From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
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Percentage of participants with clinical laboratory test results above/below certain threshold
時間枠:At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
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At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
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Percentage of participants with vital signs above/below certain threshold
時間枠:At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold
時間枠:At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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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
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)
2019年2月7日
一次修了 (実際)
2019年4月29日
研究の完了 (実際)
2019年4月29日
試験登録日
最初に提出
2019年1月31日
QC基準を満たした最初の提出物
2019年1月31日
最初の投稿 (実際)
2019年2月1日
学習記録の更新
投稿された最後の更新 (実際)
2020年5月20日
QC基準を満たした最後の更新が送信されました
2020年5月18日
最終確認日
2020年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- B7921028
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
IPD プランの説明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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
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