- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03770039
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
5. März 2019 aktualisiert von: Pfizer
A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C-PF-06700841] AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06700841 IN HEALTHY MALE SUBJECTS USING A 14C-MICROTRACER APPROACH
An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
6
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Groningen, Niederlande, 9728 NZ
- PRA Health Sciences
-
Utrecht, Niederlande, 3584 BL
- PRA Health Sciences Utrecht
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
Exclusion Criteria:
- Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
- Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
- History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
- Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
- Use of herbal supplements within 28 days prior to the first dose of study medication
- Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen 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 Pfizer
- Inability to have at least one bowel movement every 2 days on average eGFR of <90 mL/mim/1.73 m2 based on MDRD equation
- Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 2-period, fixed sequence
fixed sequence with 2 treatment period
|
Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
60 mg unlabeled PF-06700841 oral dose in 2nd period
30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
mass balance_urine
Zeitfenster: hour 0 up to 312 hours post dose
|
cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered
|
hour 0 up to 312 hours post dose
|
|
mass balance_feces
Zeitfenster: hour 0 up to 312 hours post dose
|
cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered
|
hour 0 up to 312 hours post dose
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
metabolite identification_plasma
Zeitfenster: hour 0 up to 312 hours post dose
|
metabolic identification and profiling in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma Cmax for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
maximum concentration of total 14C radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma Tmax for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
time with highest concentration of radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma AUClast for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
area under curve of total 14C radioactivity in plasma from time 0 to tlast following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma AUCinf for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
area under curve of total 14C radioactivity in plasma from time 0 to infinite following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
Oral clearance for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
oral clearance (CL/F) of total activity following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma half-life for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
half-life (t1/2) of total radioactivity in plasma following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
volume of distribution for total 14C radioactivity
Zeitfenster: hour 0 up to 312 hours post dose
|
apparent volume of distribution (Vz/F) of total radioactivity following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
plasma Cmax for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
maximum concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma Tmax for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
time with highest concentration of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUClast for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
area under curve of PF-06700841 in plasma from time 0 to tlast following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUCinf for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
area under curve of PF-06700841 in plasma from time 0 to infinite following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
Oral clearance for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
oral clearance (CL/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma half-life for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
half-life (t1/2) of PF-06700841 in plasma following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
volume of distribution for PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
apparent volume of distribution (Vz/F) of PF-06700841 following a single oral dose of 14C-labeled or unlabeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma Cmax for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
maximum concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma Tmax for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
time with highest concentration of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUClast for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
area under curve of 14C-labeled PF-06700841 in plasma from time 0 to tlast following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma AUCinf for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
area under curve of 14C-PF-06700841 in plasma from time 0 to infinite following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
clearance for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
clearance (CL) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
plasma half-life for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
half-life (t1/2) of 14C-labeled PF-06700841 in plasma following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
volume of distribution for 14C-labeled PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
volume of distribution (Vz/F) of 14C-labeled PF-06700841 following a single iv dose of 14C-labeled PF-06700841
|
hour 0 up to 96 hours post dose
|
|
unchanged PF-06700841 recovered in urine
Zeitfenster: hour 0 up to 96 hours post dose
|
percentage of unchanged PF-06700841 recovered in urine (Ae%) following a single oral dose of PF-06700841
|
hour 0 up to 96 hours post dose
|
|
renal clearance of PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
renal clearance (CLr) following a single oral dose of PF-06700841 (Ae%/AUCinf for PF-06700841)
|
hour 0 up to 96 hours post dose
|
|
Bioavailability of oral PF-06700841
Zeitfenster: hour 0 up to 96 hours post dose
|
Absolute bioavailability (F) following a single oral dose relative to a single iv dose of PF-06700841
|
hour 0 up to 96 hours post dose
|
|
Fraction absorbed of oral PF-06700841
Zeitfenster: hour 0 up to 144 hours post dose
|
Fraction absorbed in gut (Fa) following oral dose of PF-06700841
|
hour 0 up to 144 hours post dose
|
|
metabolite identification_urine
Zeitfenster: hour 0 up to 312 hours post dose
|
metabolic identification and profiling in urine following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
|
metabolite identification_feces
Zeitfenster: hour 0 up to 312 hours post dose
|
metabolic identification and profiling in feces following a single oral dose of 14C-labeled PF-06700841
|
hour 0 up to 312 hours post dose
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
10. Dezember 2018
Primärer Abschluss (Tatsächlich)
21. Februar 2019
Studienabschluss (Tatsächlich)
21. Februar 2019
Studienanmeldedaten
Zuerst eingereicht
6. Dezember 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Dezember 2018
Zuerst gepostet (Tatsächlich)
10. Dezember 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. März 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. März 2019
Zuletzt verifiziert
1. März 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- B7931014
- 2018-002403-34 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
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
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Ja
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .