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

7 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

16

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Pfizer Clinical Research Unit - New Haven

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of participants with treatment-emergent adverse events (AEs)
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de abril de 2026

Conclusão Primária (Real)

24 de junho de 2026

Conclusão do estudo (Real)

26 de junho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • C4901006

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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