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Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544

2026年7月7日 更新者:Pfizer

A Phase 1 Open-Label, Single-Dose, Two Cohort Crossover Study to Evaluate the Relative Bioavailability of a Test Formulation of PF-07799933 and the Effect of a High-Fat Meal on Plasma Pharmacokinetics of PF-07799933 and PF 07799544 Administered in Combination, and the Impact of a Proton Pump Inhibitor on the Plasma Pharmacokinetics of PF-07799933, in Healthy Participants.

The purpose of this study is to evaluate the relative bioavailability (rBA) of the Form 2 film-coated tablet of PF-07799933 intended for use in future studies compared to the current Form 1 tablet of PF-07799933 used in Phase 1 studies. Additionally this study will also evaluate the effect of a high-fat meal on the plasma pharmacokinetics (PK), i.e, the rBA compared to overnight fasting, of PF-07799933 and PF-07799544 following concurrent single-dose oral administration of Form 2 film-coated tablet formulation of PF-07799933 with PF-07799544. Finally, this study will also assess the impact of a proton pump inhibitor (a type of acid reducing agent) on PF-07799933 PK of the Form 2 film-coated tablet formulation. These data will be used to inform administration of PF-07799933 and PF-07799544 with food and acid reducing agents in future clinical trials.

調査の概要

詳細な説明

This is a Phase 1, open-label, randomized, single-dose, 2-cohort study: a three period two sequence crossover (Relative Bioavailability and Food Effect) cohort in healthy adult participants, and a two-period single sequence cohort (Proton Pump Inhibitor) in healthy adult participants. Cohort 1 of this study, which has 3 periods, will evaluate the impact of the Form 2 film-coated tablet of PF-07799933 (test formulation) compared to the Form 1 tablet of PF-07799933 (reference formulation) used in the C4901001 and C4761001 Phase 1 studies (Period 1 and Period 2). This cohort (Cohort 1) will also evaluate the effect of a high fat meal on plasma pharmacokinetics (ie, the relative bioavailability compared to overnight fasting) of the Form 2 film-coated tablet of PF-07799933 and of PF-07799544 following concurrent single-dose administrations of 300 mg of PF 07799933 and the optimized dose identified from an ongoing clinical study (either 7.5 or 12 mg) of PF 07799544 to healthy adult participants (Period 3). Cohort 2, which has two periods, will evaluate the plasma pharmacokinetics of PF-07799933 before (Period 1) and after administration of the proton pump inhibitor rabeprazole (20 mg BID for 3 days and once in the morning for the last dose [seven total doses]) (Period 2). Cohort 2 will be conducted using the Form 2 film-coated tablet of PF-07799933 in both periods.

研究の種類

介入

入学 (実際)

16

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

    • Connecticut
      • New Haven、Connecticut、アメリカ、06511
        • Pfizer Clinical Research Unit - New Haven

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

  • Female participants of non-childbearing potential and male participants 18 to 65 years of age (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs.
  • BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion Criteria

  • Evidence or history of clinically significant uveitis, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, 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, chronic diarrhea, - inflammatory bowel disease).
  • History of HIV infection, hepatitis B, or hepatitis C
  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (eg,glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease (including evidence of macular degeneration); blurred vision.
  • Any evidence of active bacterial, fungal, or viral infection
  • Participants who have undergone major surgery ≤ 2 weeks prior to starting study treatment
  • Participants with known or suspected hypersensitivity to active ingredient/excipients
  • Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the 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 study intervention. Prior or concomitant use of proton pump inhibitors within 7 days prior to first dose of study intervention is prohibited. Also prohibited is prior or concomitant use of any medications or substances that are:
  • For Cohort 1: strong or moderate inducers of CYP3A4/5, CYP2C9, or UGT2B7 within 28 days or 5 half-lives plus 10 days prior to first dose of study intervention, and strong or moderate inhibitors of CYP3A4/5, CYP2C9, UGT1A9 or UGT2B7 within 5 half-lives or 10 days (whichever is longer) prior to first dose of study intervention.
  • For Cohort 2: strong or moderate inducers of UGT2B7 within 28 days or 5 half-lives plus 10 days prior to first dose of study intervention, and strong or moderate inhibitors of UGT2B7 within 5 half-lives or 10 days (whichever is longer) prior to first dose of study intervention.
  • Current use of concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
  • Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
  • A positive urine drug test. A single repeat for positive drug screen may be allowed.
  • Use of tobacco or nicotine containing products within 3 months of screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥ 140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • An eGFR < 60 (units of mL/min/1.73 m²) as determined by the CKD-EPI equation
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

ALT, AST, Bilirubin ≥1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN, Hemoglobin ≤ 11 g/dL ANC ≤ 1.5 × 109/L, Platelets ≤ 150,000/mm3/.

- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.

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: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
実験的:PF-07799933 Form 1 Tablet Arm with PF-07799544 Fasted
Cohort 1 Period 1: Participants receive PF-07799933 tablets in Combination With PF-07799544
Participants receive Form 1 in a single dose of tablet in a single dose combination fasted
実験的:PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 Fasted
Cohort 1 Period 2: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544
Participants receive Form 2 in a single dose of tablet in a single dose combination fasted
実験的:PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 under Fed Conditions
Cohort 1 Period 3: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 following a High-Fat Meal
Participants receive Form 2 in a single dose of tablet in a single dose combination in the fed state
実験的:PF-07799933 Form 2 Tablet Arm
Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets
Participants receive Form 2 in a single dose of tablet fasted
実験的:PF-07799933 Form 2 Tablet Arm following Rabeprazole Pretreatment
Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets following rabeprazole treatment
Participants receive Form 2 in a single dose of tablet following rabeprazole pre-treatment fasted

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
時間枠
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed fasted
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
時間枠:0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose

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 (AEs)
時間枠:From Baseline up to Day 35
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. AEs as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
Number of participants with treatment-emergent laboratory abnormalities.
時間枠:From Baseline up to Day 35
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. Laboratory abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
Number of participants with treatment-emergent vital sign abnormalities.
時間枠:From Baseline up to Day 35
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. Vital sign abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
Number of participants with treatment-emergent electrocardiogram (ECG) abnormalities.
時間枠:From Baseline up to Day 35
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. ECG abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
Number of participants with treatment-emergent physical exam abnormalities.
時間枠:From Baseline up to Day 35
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. Physical exam abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent AEs.
時間枠:From Baseline up to Day 35
AEs characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent laboratory abnormalities.
時間枠:From Baseline up to Day 35
Laboratory abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent ECG abnormalities.
時間枠:From Baseline up to Day 35
ECG abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with physical exam abnormalities.
時間枠:From Baseline up to Day 35
Physical exam abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
From Baseline up to Day 35

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:Pfizer CT.gov Call Center、Pfizer

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4月10日

一次修了 (実際)

2026年6月24日

研究の完了 (実際)

2026年6月26日

試験登録日

最初に提出

2026年4月6日

QC基準を満たした最初の提出物

2026年4月29日

最初の投稿 (実際)

2026年5月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月9日

QC基準を満たした最後の更新が送信されました

2026年7月7日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • C4901006

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

米国で製造され、米国から輸出された製品。

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。

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