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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 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

9

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

    • Nottinghamshire
      • Nottingham, Nottinghamshire, Vereinigtes Königreich, NG11 6JS
        • Quotient Clinical

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

30 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

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: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Amount of radioactivity eliminated in urine
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in feces
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Hematology
Zeitfenster: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Clinical chemistry
Zeitfenster: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Urinalysis
Zeitfenster: Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Blood pressure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Screening to Day 28
Screening to Day 28
Physical examination
Zeitfenster: Screening and Day 8
Screening and Day 8
Tlag of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cmax of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Tmax of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUClast of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
%AUCextrap of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUCinf of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Lambda-z of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
T1/2 of CORT125134
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Mean Residence Time (MRT) of CORT125134
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Pui Leung, MBChB, Quotient Clinical

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

1. August 2016

Primärer Abschluss (Tatsächlich)

1. September 2016

Studienabschluss (Tatsächlich)

1. September 2016

Studienanmeldedaten

Zuerst eingereicht

6. Dezember 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Februar 2017

Zuerst gepostet (Tatsächlich)

1. März 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. August 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. August 2019

Zuletzt verifiziert

1. August 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

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

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