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A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Taken Up Into the Blood in Healthy Adults
A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 4-SEQUENCE SINGLE-DOSE CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF PRIFETRISTAT DRUG PRODUCT DIFFERING IN PARTICLE SIZE DISTRIBUTION
The purpose of this study is to understand the relative amount of drug that enters bloodstream from prifetrastat product lots differing in active ingredient particle size distribution.
The study is seeking participants who are:
Healthy males and females of non-childbearing potential >=18 years of age at screening
Participants in the study will receive a single dose of prifetrastat by mouth. After at least 14 days, they will receive another dose of prifetrastat by mouth. Each dose received by the patient will be in tablet form. The sequence in which tablets are given will be random.
The study will help understand how the difference in particle size distributions of the tablets may, or may not, affect how the drug is absorbed, processed, and eliminated by the body.
Participants will remain in the study clinic for 21 days. However, they may be permitted to leave between periods, and will have one follow-up contact.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Pfizer CT.gov Call Center
- Telefoonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studie Locaties
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Bruxelles-capitale, Région de
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Brussels, Bruxelles-capitale, Région de, België, B-1070
- Werving
- Pfizer Clinical Research Unit - Brussels
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion
- Females of non-childbearing potential and males >=18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- BMI of 18-32 kilogram per meter square(Kg/m^2); and a total body weight >50 kg (110 lb).
Exclusion
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
- Prior use of epigenetic modifying agents. Participants will only be permitted to enroll in a single arm of this study (cannot participate in Arm 1 and Arm 2).
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of prifetrastat
- Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Arm 1 prifetrastat
Crossover
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Reference Treatment
Test 1 Treatment
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Actieve vergelijker: Arm 2 prifetrastat
Crossover
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Reference Treatment
Test 2 Treatment
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
Tijdsspanne: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment
Tijdsspanne: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 1 treatment of prifetrastat (AUClast If data does not permit AUCinf)
Tijdsspanne: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment
Tijdsspanne: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 2 treatment of prifetrastat (AUClast If data does not permit AUCinf)
Tijdsspanne: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Test 2 prifetrastat treatment
Tijdsspanne: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to Day 35 after the last dose of study intervention in Period 2
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Up to Day 35 after the last dose of study intervention in Period 2
|
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Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Tijdsspanne: Up to Day 35 after the last dose of study intervention in Period 2
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Up to Day 35 after the last dose of study intervention in Period 2
|
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Number of Participants With Clinically Significant Abnormalities in Vital Signs
Tijdsspanne: Up to Day 35 after the last dose of study intervention in Period 2
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Up to Day 35 after the last dose of study intervention in Period 2
|
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Tijdsspanne: Up to Day 35 after the last dose of study intervention in Period 2
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Up to Day 35 after the last dose of study intervention in Period 2
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Number of Participants With Clinically Significant Physical Examination Abnormalities
Tijdsspanne: Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- C4551017
- 2026-526038-26-00 (Register-ID: CTIS (EU))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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