- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03067376
A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
7. august 2019 oppdatert av: Corcept Therapeutics
An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects
The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.
Studieoversikt
Detaljert beskrivelse
The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood.
Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces.
Safety and tolerability were assessed.
Studietype
Intervensjonell
Registrering (Faktiske)
9
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Nottinghamshire
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Nottingham, Nottinghamshire, Storbritannia, NG11 6JS
- Quotient Clinical
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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
30 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy males or healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause])
- Age 30 to 65 years of age
- A history of regular bowel movements (averaging ≥1 and ≤3 stools per day)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Male participants must agree to use an adequate method of contraception
- Participants are willing to abide by the study restrictions
Exclusion Criteria:
- Participation in a clinical research study within the previous 3 months
- Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
- Females of childbearing potential (female participants must have a negative urine pregnancy test)
- Male Participants with pregnant partners
- Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.
- Positive drugs of abuse test result
- Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted
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: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Amount of radioactivity eliminated in urine
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Amount of radioactivity eliminated in urine and feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Cumulative amount of radioactivity eliminated in urine
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
Cumulative amount of radioactivity eliminated in feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
Cumulative amount of radioactivity eliminated in urine and feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: peak plasma concentration (Cmax)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: time to reach maximum observed concentration (tmax)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
|
PK of total radioactivity: elimination half-life (t1/2)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Metabolic profiling and structural identification in plasma, urine and feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Hematology
Tidsramme: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Clinical chemistry
Tidsramme: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Urinalysis
Tidsramme: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Blood pressure
Tidsramme: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Heart rate
Tidsramme: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Electrocardiogram
Tidsramme: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
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Percentage of subjects with adverse events
Tidsramme: Screening to Day 28
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Screening to Day 28
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Physical examination
Tidsramme: Screening and Day 8
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Screening and Day 8
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Tlag of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Cmax of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Tmax of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUClast of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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%AUCextrap of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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AUCinf of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Lambda-z of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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T1/2 of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Mean Residence Time (MRT) of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Apparent oral clearance (CL/F) of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Apparent volume of distribution (Vz/F) of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of circulating radioactivity in plasma
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of the dose in urine
Tidsramme: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Number of metabolites >10% of the dose in feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pui Leung, MBChB, Quotient Clinical
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. august 2016
Primær fullføring (Faktiske)
1. september 2016
Studiet fullført (Faktiske)
1. september 2016
Datoer for studieregistrering
Først innsendt
6. desember 2016
Først innsendt som oppfylte QC-kriteriene
23. februar 2017
Først lagt ut (Faktiske)
1. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CORT125134-121
- 2016-000668-41 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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. .
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