- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02571192
A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
30. april 2019 oppdatert av: Mirum Pharmaceuticals, Inc.
A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects
The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
8
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53704
- Covance Madison Clinical Research Unit
-
-
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 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Age between 18 and 50 years, inclusive, at the time of consent.
- Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
- Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
- Ability to swallow all investigational product.
- A minimum of 1 bowel movement per day.
Exclusion Criteria:
- History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
- Current or relevant history of physical or psychiatric illness.
- Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
- Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
- Known history of alcohol or other substance abuse within the last year.
- Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
Within 30 days prior to the dose of investigational product:
- Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
- Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
- Have had any substantial changes in eating habits, as assessed by the investigator.
- Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
- Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
- A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
- Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
- A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
- Use of tobacco in any form
- Routine consumption of more than 2 units of caffeine per day
- Current use of any medication including over-the-counter, herbal, or homeopathic preparations
- An inability to follow a standardized diet and meal schedule or inability to fast
- Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
- Exposure to clinically significant radiation within 12 months prior to the 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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental Drug
single oral dose radiolabelled 50mg of SHP626
|
single oral dose 50mg SHP626 with approximately 5.95 μCi RAD
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
Tidsramme: Day 1 to day 10
|
Day 1 to day 10
|
|
Total radioactivity (RAD) in whole blood and plasma
Tidsramme: Day 1 to day 10
|
Day 1 to day 10
|
|
To determine the total RAD in urine and feces.
Tidsramme: Day 1 to day 10
|
Day 1 to day 10
|
|
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
Tidsramme: Day 1 to day 10
|
Day 1 to day 10
|
|
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
Tidsramme: Day 1 to Day 10
|
Day 1 to Day 10
|
|
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
Tidsramme: Day 1 to Day 10
|
Day 1 to Day 10
|
|
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
Tidsramme: Day 1 to Day 10
|
Day 1 to Day 10
|
|
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
Tidsramme: Day 1-10
|
Day 1-10
|
|
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
Tidsramme: Day 1-10
|
Day 1-10
|
|
Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
Tidsramme: Day 1-10
|
Day 1-10
|
|
Excreted Percent of RAD recovered in stool over the dosing interval
Tidsramme: Day 1-10
|
Day 1-10
|
|
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
Tidsramme: Day 1-10
|
Day 1-10
|
|
Excreted Percent of RAD recovered in urine over the dosing interval
Tidsramme: Day 1-10
|
Day 1-10
|
|
Renal Clearance (CLR ) of 50mg [14C]-SHP626
Tidsramme: Day 1 -10
|
Day 1 -10
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification
Tidsramme: Day 1 to day 10
|
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
|
Day 1 to day 10
|
|
Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification
Tidsramme: Day 1 to day 10
|
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
|
Day 1 to day 10
|
|
Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting
Tidsramme: Day 1 to day 10
|
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
|
Day 1 to day 10
|
|
Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings
Tidsramme: Screening to day 7
|
AEs will be coded using the agreed upon version of MedDRA.
The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term.
TEAEs will be further summarized by severity and relationship to investigational product.
AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.
|
Screening to day 7
|
|
Changes from baseline in vital signs
Tidsramme: Screening to day 7
|
Screening to day 7
|
|
|
Changes from baseline in ECGs
Tidsramme: Screening to day 7
|
Screening to day 7
|
|
|
Changes from baseline in hematology
Tidsramme: Screening to day 7
|
Screening to day 7
|
|
|
Changes from baseline in coagulation
Tidsramme: Screening to day 7
|
Screening to day 7
|
|
|
Changes in baseline in urinalysis
Tidsramme: Screening to day 7
|
Screening to day 7
|
|
|
Changes in baseline in chemistry
Tidsramme: Screening to day 7
|
Screening to day 7
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Nicholas Siebers, MD, Covance Clinical Pharmacology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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
1. oktober 2015
Primær fullføring (Faktiske)
1. oktober 2015
Studiet fullført (Faktiske)
1. oktober 2015
Datoer for studieregistrering
Først innsendt
30. september 2015
Først innsendt som oppfylte QC-kriteriene
6. oktober 2015
Først lagt ut (Anslag)
8. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHP626-102
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Ikke-alkoholisk Steatohepatitt
-
Ornit CohenProf Doron ZamirUkjentNAFLD - Non Alcoholic Fatty Liver DiseaseIsrael
-
ContextVision ABUniversity of WashingtonRekrutteringNAFLD - Non-Alcoholic Fatty Liver Disease | MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseForente stater
-
Cyprus University of TechnologyCyprus State Heath Organization ServicesHar ikke rekruttert ennåNAFLD | NAFLD (Nonalcoholic Fatty Liver Disease) | NAFLD - Non-Alcoholic Fatty Liver Disease | MASLD | MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseKypros
-
University of AarhusDanish Diabetes AcademyFullførtType 2 diabetes | NAFLD - Non-Alcoholic Fatty Liver DiseaseDanmark
-
University of NottinghamNottingham University Hospitals NHS TrustRekrutteringNAFLD | Ikke-alkoholisk fettleversykdom | Ikke-alkoholisk fettleversykdom (NAFLD) | NAFLD - Ikke-alkoholisk fettleversykdom | NAFLD (Alkoholisk fettleversykdom) | NAFLD (Nonalcoholic Fatty Liver Disease) | NAFLD - Non-Alcoholic Fatty Liver Disease | MASLD | Metabolsk dysfunksjon-assosiert Steatotisk leversykdom og andre forholdStorbritannia
-
Changi General HospitalNational University of SingaporeRekrutteringHypertensjon | Telemedisin | Dyslipidemi | Overvekt og type 2 diabetes | NAFLD - Non-Alcoholic Fatty Liver DiseaseSingapore
-
Estrella Biopharma, Inc.Eureka Therapeutics Inc.RekrutteringLymfom | Lymfom, Non-Hodgkin | Non-Hodgkins lymfom | Non-Hodgkin lymfom | Refraktær B-celle non-Hodgkin lymfom | Refraktært non-Hodgkin lymfom | Høygradig B-celle lymfom | CNS lymfom | Lymfomer Non-Hodgkins B-celle | Residiverende non-Hodgkin lymfom | Lymfom, Non-Hodgkins | Stort B-celle lymfom | Lymfom, Non-Hodgkins... og andre forholdForente stater
-
Caribou Biosciences, Inc.RekrutteringLymfom | Lymfom, Non-Hodgkin | B-celle lymfom | Non Hodgkin lymfom | Refraktær B-celle non-Hodgkin lymfom | Residiverende non-hodgkin lymfom | B-celle non-Hodgkins lymfomForente stater, Australia, Israel
-
Chongqing Precision Biotech Co., LtdRekrutteringNon Hodgkin lymfom | Refraktært non-Hodgkin lymfom | Residiverende non-Hodgkin lymfomKina
-
Marker Therapeutics, Inc.RekrutteringHodgkin lymfom | Non Hodgkin lymfom | Hodgkin lymfom, voksen | Non-Hodgkin lymfom, voksen | Non-Hodgkin lymfom, ildfast | Non-Hodgkin lymfom, tilbakefall | Hodgkins lymfom, tilbakefall, voksenForente stater
Kliniske studier på SHP626
-
Mirum Pharmaceuticals, Inc.AvsluttetIkke-alkoholisk SteatohepatittForente stater, Storbritannia, Canada, Puerto Rico
-
Mirum Pharmaceuticals, Inc.FullførtIkke-alkoholisk SteatohepatittForente stater
-
Mirum Pharmaceuticals, Inc.AvsluttetIntrahepatisk kolestase ved graviditetForente stater, Storbritannia, New Zealand
-
Mirum Pharmaceuticals, Inc.Aktiv, ikke rekrutterendePrimær skleroserende kolangittForente stater, Israel, Canada, Sveits, Belgia, Spania, Frankrike, Tyskland, Italia, Nederland, Storbritannia, Australia, Brasil, Argentina
-
Mirum Pharmaceuticals, Inc.Fullført
-
Mirum Pharmaceuticals, Inc.RekrutteringPrimær biliær kolangitt | PBCForente stater, Nederland, Storbritannia, Israel, Spania, Belgia, Canada, Tyskland, Italia, Japan, Sveits, Kina, Frankrike, Argentina, Brasil