- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07563894
Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Arzneimittel: PF-07799933 tablets with PF-07799544 fasted
- Arzneimittel: PF-07799933 film-coated tablets with PF-07799544 fasted
- Arzneimittel: PF-07799933 film-coated tablets with PF-07799544 fed
- Arzneimittel: PF-07799933 film-coated tablets fasted
- Arzneimittel: PF-07799933 film-coated tablets following rabeprazole pretreatment fasted
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06511
- Pfizer Clinical Research Unit - New Haven
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of participants with treatment-emergent adverse events (AEs)
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- C4901006
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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