A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
-
Bruxelles, Belgio, B-1070
- Pfizer Investigational Site
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Women must be of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: Coorte 1
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Sperimentale: Coorte 2
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Sperimentale: Coorte 3
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Sperimentale: Coorte 4
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
|
Sperimentale: Coorte 5
|
Solution, doses range from 20 to 200 mg, single dose
Solution, single dose
Methylcellulose suspension, doses range 125 to 500 mg, single dose
suspension, single dose
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
Methylcellulose or simethicone suspension, 500 mg dose, single dose
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Area Under the Curve From Time Zero to 24 hour [AUC24]
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax)
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Apparent Oral Clearance (CL/F)
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Plasma Decay Half-Life (t1/2)
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Apparent Volume of Distribution (Vz/F)
Lasso di tempo: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose
|
|
Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)
Lasso di tempo: 0 to 24 hours post-dose
|
0 to 24 hours post-dose
|
|
Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)
Lasso di tempo: 0 to 24 hours post-dose
|
0 to 24 hours post-dose
|
|
Renal Clearance (CLr)
Lasso di tempo: 0 to 24 hours post-dose
|
0 to 24 hours post-dose
|
|
Oral temperature
Lasso di tempo: 0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
|
0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose
|
Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- B5211001
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