- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03770039
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
5. mars 2019 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Groningen, Nederland, 9728 NZ
- PRA Health Sciences
-
Utrecht, Nederland, 3584 BL
- PRA Health Sciences Utrecht
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
mass balance_urine
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
metabolite identification_plasma
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. desember 2018
Primær fullføring (Faktiske)
21. februar 2019
Studiet fullført (Faktiske)
21. februar 2019
Datoer for studieregistrering
Først innsendt
6. desember 2018
Først innsendt som oppfylte QC-kriteriene
6. desember 2018
Først lagt ut (Faktiske)
10. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B7931014
- 2018-002403-34 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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