A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
16 luglio 2015 aggiornato da: Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects
PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
39
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Brussels, Belgio, B-1070
- Pfizer Clinical Research Unit
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 55 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Healthy male, or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Cohort 1: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
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PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
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Sperimentale: Cohort 2: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
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PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Sperimentale: Cohort 3: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
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PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Sperimentale: Cohort 4: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Sperimentale: Cohort 5: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Sperimentale: Cohort 6: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
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Sperimentale: Cohort 7: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Sperimentale: Cohort 8: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
|
Sperimentale: Cohort 9: PF-06409577 or placebo
Single ascending doses of PF-06409577 or placebo to investigate the safety, tolerability, and PK.
|
PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Number of Participants With Adverse Events (AEs)
Lasso di tempo: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Laboratory Test Values of Potential Clinical Importance
Lasso di tempo: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
Lasso di tempo: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
Lasso di tempo: 0-48 hours post dose
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0-48 hours post dose
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Number of Participants With Echocardiogram Findings of Potential Clinical Importance
Lasso di tempo: 0-48 hours post dose
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0-48 hours post dose
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
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Area under the plasma concentration time-curve from zero to time 24 hours post dose (AUC24)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
|
AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity).
It is obtained from AUC (0 - t) plus AUC (t - infinity).
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Maximum Observed Plasma Concentration (Cmax)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Plasma Decay Half-Life (t1/2)
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Apparent Oral Clearance (CL/F) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Apparent Volume of Distribution (Vz/F) for PF-06409577
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
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0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
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Total amount of PF-06409577 excreted in the urine over 24 hours (Ae24)
Lasso di tempo: 0-24 hours post dose
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Total amount of unchanged drug excreted in the urine over 24 hours.
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0-24 hours post dose
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Total amount of PF-06409577 excreted in the urine over 24 hours, expressed as percent of dose (%Ae24)
Lasso di tempo: 0-24 hours post dose
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Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose.
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0-24 hours post dose
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Renal clearance for PF-06409577
Lasso di tempo: 0-24 hours post dose
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Renal clearance of a drug is a measure of the rate at which a drug is excreted unchanged into urine.
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0-24 hours post dose
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2014
Completamento primario (Effettivo)
1 giugno 2015
Completamento dello studio (Effettivo)
1 giugno 2015
Date di iscrizione allo studio
Primo inviato
6 novembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
6 novembre 2014
Primo Inserito (Stima)
10 novembre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
20 luglio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 luglio 2015
Ultimo verificato
1 luglio 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- B7881001
- FIH (Altro identificatore: Alias Study Number)
- 2014-004022-18 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .