- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07575906
A Study to Learn How a Single Dose of the Study Medicine Called PF-08057418 is Tolerated in the Body of Healthy Adults.
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF SINGLE ASCENDING ORAL DOSES OF PF-08057418 IN HEALTHY ADULT PARTICIPANTS
The purpose of this clinical trial is to learn about the safety and pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from body after participant take it) of the study medicine (called PF-08057418) in healthy people.
This study is seeking participants who are healthy adults.
Everyone who participates in this study will receive the study medicine. The study medicine may be given as a solution or as a tablet. Participants will be dosed once a week for 5 weeks.
The investigator will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe.
Participants will be involved in this study for up to 13 weeks from screening to follow-up visit. Participants stay in the study clinic for the 5 week dosing duration of the study, with two follow-up visits subsequently, either in person or by telephone call.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06511
- Rekruttering
- Pfizer Clinical Research Unit -New Haven
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adults 18 to 60 years of age (or the minimum age of consent per local regulations) at screening.
- Healthy participants, as determined by medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
- Body mass index (BMI) between 16 and 32 kg/m² and body weight >50 kg (110 lb).
- Willing and able to comply with all study procedures, including scheduled visits, treatment plans, laboratory testing, and lifestyle restrictions.
Exclusion Criteria:
- History or evidence of clinically significant medical conditions, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic diseases (excluding untreated, asymptomatic seasonal allergies at the time of dosing).
- Any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C, or positive screening tests for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is permitted.
- History of phototoxicity or photosensitivity.
- Prior use of any investigational drug or vaccine within 30 days or 5 half-lives (whichever is longer) before the first study dose, or participation in another investigational study during this study.
Elevated blood pressure at screening:
- 140/90 mm Hg for participants <60 years, or
- 150/90 mm Hg for participants ≥60 years, after at least 5 minutes of supine rest (average of 3 measurements).
- Renal impairment, defined as estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m².
- Clinically significant ECG abnormalities, including but not limited to QT corrected for heart rate by Fridericia's cube root formula (QTcF) >450 ms, complete left bundle branch block, evidence of myocardial infarction or ischemia, second- or third-degree AV block, or clinically significant arrhythmias.
- Clinically significant laboratory abnormalities at screening, including ALT, AST, or total bilirubin ≥1.05 × ULN (participants with Gilbert's syndrome may be eligible if direct bilirubin is ≤ULN).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: PF-08057418
Participants will receive single oral solution or tablet dose(s) of PF-08057418
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solution or tablet (fasted/fed)
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Placebo komparator: Placebo
Participants will receive single oral solution or tablet dose(s) of placebo.
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solution or tablet (fasted/fed)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to 10 weeks
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Assessment of TEAEs, SAEs, clinical laboratory values, vital signs, continuous cardiac monitoring and 12-lead ECGs
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Up to 10 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Pharmacokinetics (PK): Area under the concentration-time curve (AUC) of PF-08057418
Tidsramme: Up to 10 weeks
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Up to 10 weeks
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PK: Maximum Observed Plasma Concentration (Cmax) of PF-08057418
Tidsramme: Up to 10 weeks
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Up to 10 weeks
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PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-08057418
Tidsramme: Up to 10 weeks
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Up to 10 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- C6471002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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