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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Luoghi di studio
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Florida
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Miami Lakes, Florida, Stati Uniti, 33016
- Floridian Clinical Research
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Tampa, Florida, Stati Uniti, 33603
- Genesis Clinical Research, LLC
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Minnesota
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Saint Paul, Minnesota, Stati Uniti, 55114
- Nucleus Network Minneapolis
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Prifetrastat
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of Treatment-Emergent Adverse Events (AE) by Severity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From Baseline up to Day 16
|
From Baseline up to Day 16
|
|
Number of Participants With Abnormalities in Physical Examination
Lasso di tempo: From Baseline up to Day 16
|
From Baseline up to Day 16
|
|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Lasso di tempo: From Baseline up to Day 16
|
From Baseline up to Day 16
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C4551013
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
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