A Study to Learn About the Study Medicine Called Prifetrastat in People With Renal Impairment
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF PRIFETRASTAT IN PARTICIPANTS WITH MODERATE AND SEVERE RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL RENAL FUNCTION.
The primary purpose of this study is to understand how the body processes the study medicine, called prifetrastat, in people with renal impairment compared to healthy people with normal kidney function. Renal impairment means that a person has worse kidney function than normal. The study will also look at the safety and tolerability of prifetrastat in people with renal impairment compared to healthy people with normal kidney function.
This study is seeking participants who:
- Have moderate or severe renal impairment or
- Healthy people with normal kidney function
All participants in this study will receive a single dose of prifetrastat. The study medicine will be given by mouth at the study clinic. We will compare experiences of people with renal impairment and healthy people with normal kidney function.
Participants will take part in this study for about 2 months. During this time, they will stay at the study clinic for 8 to 16 days.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studienorte
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Florida
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Miami Lakes, Florida, Vereinigte Staaten, 33016
- Floridian Clinical Research
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Tampa, Florida, Vereinigte Staaten, 33603
- Genesis Clinical Research, LLC
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Minnesota
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Saint Paul, Minnesota, Vereinigte Staaten, 55114
- Nucleus Network Minneapolis
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria
- Female of nonchildbearing potential or males, 18 to 90 years of age at screening.
- Body mass index (BMI) of 16-40 kg/m2; and a total body weight >50 kg (110 lb).
- Stable renal function that matches the classification of either moderate renal impairment, severe renal impairment, or normal renal function.
Exclusion Criteria
- Any condition possibly affecting drug absorption
- Acute renal disease
- Renal allograft recipient
- Renal transplant recipient
- Urinary incontinence without catheterization
- Current use of any prohibited concomitant medication(s)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Moderate Renal Impairment (Cohort 1)
Prifetrastat administered by mouth as a single dose in participants with moderate renal impairment (eGFR = 30-59 mL/min). |
Prifetrastat administered by mouth as a single dose.
Andere Namen:
|
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Experimental: Severe Renal Impairment (Cohort 2)
Prifetrastat administered by mouth as a single dose in participants with severe renal impairment (eGFR < 30 mL/min). |
Prifetrastat administered by mouth as a single dose.
Andere Namen:
|
|
Aktiver Komparator: Normal Renal Function (Cohort 3)
Prifetrastat administered by mouth as a single dose in participants with normal renal function (eGFR ≥ 90 mL/min). |
Prifetrastat administered by mouth as a single dose.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prifetrastat
Zeitfenster: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax) of Prifetrastat
Zeitfenster: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 360 hours post-dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Number of Treatment-Emergent Adverse Events (AE) by Severity
Zeitfenster: From Baseline through follow-up, up to 35 days after last dose of study drug
|
From Baseline through follow-up, up to 35 days after last dose of study drug
|
|
Number of Participants With Clinically Significant Clinical Laboratories Abnormalities
Zeitfenster: From Baseline through follow-up, up to 35 days after last dose of study drug
|
From Baseline through follow-up, up to 35 days after last dose of study drug
|
|
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate
Zeitfenster: From Baseline up to Day 16
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From Baseline up to Day 16
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Number of Participants With Abnormalities in Physical Examination
Zeitfenster: From Baseline up to Day 16
|
From Baseline up to Day 16
|
|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Zeitfenster: From Baseline up to Day 16
|
From Baseline up to Day 16
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C4551013
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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