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A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

7. august 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Nottinghamshire
      • Nottingham, Nottinghamshire, Det Forenede Kongerige, NG11 6JS
        • Quotient Clinical

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
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
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
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
Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: peak plasma concentration (Cmax)
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
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
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
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

Sekundære resultatmål

Resultatmål
Tidsramme
Hematology
Tidsramme: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Clinical chemistry
Tidsramme: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Urinalysis
Tidsramme: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Blood pressure
Tidsramme: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Heart rate
Tidsramme: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Electrocardiogram
Tidsramme: Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Percentage of subjects with adverse events
Tidsramme: Screening to Day 28
Screening to Day 28
Physical examination
Tidsramme: Screening and Day 8
Screening and Day 8
Tlag of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cmax of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Tmax of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUClast of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
%AUCextrap of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUCinf of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Lambda-z of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
T1/2 of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Mean Residence Time (MRT) of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent oral clearance (CL/F) of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent volume of distribution (Vz/F) of CORT125134
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
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
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
Number of metabolites >10% of the dose in feces
Tidsramme: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Pui Leung, MBChB, Quotient Clinical

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2016

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

6. december 2016

Først indsendt, der opfyldte QC-kriterier

23. februar 2017

Først opslået (Faktiske)

1. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • CORT125134-121
  • 2016-000668-41 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med [14C]-CORT125134

Abonner