- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03067376
A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body
7 augusti 2019 uppdaterad 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
9
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Nottinghamshire
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Nottingham, Nottinghamshire, Storbritannien, NG11 6JS
- Quotient Clinical
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: [14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Amount of radioactivity eliminated in urine
Tidsram: 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
Tidsram: 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
Tidsram: 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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Cumulative amount of radioactivity eliminated in urine
Tidsram: 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
Tidsram: 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 and feces
Tidsram: 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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Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Tidsram: 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: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Tidsram: 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: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
Tidsram: 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: 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)
Tidsram: 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: elimination half-life (t1/2)
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Hematology
Tidsram: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Clinical chemistry
Tidsram: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Urinalysis
Tidsram: Screening, Day 1 pre-dose, Day 8
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Screening, Day 1 pre-dose, Day 8
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Blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Screening to Day 28
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Screening to Day 28
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Physical examination
Tidsram: Screening and Day 8
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Screening and Day 8
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Tlag of CORT125134
Tidsram: 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
Tidsram: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Tmax of CORT125134
Tidsram: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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AUClast of CORT125134
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Day 1 pre-dose to Day 8 post-dose
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Day 1 pre-dose to Day 8 post-dose
|
T1/2 of CORT125134
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 the dose in urine
Tidsram: 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
Tidsram: Day 1 pre-dose to Day 8 post-dose
|
Day 1 pre-dose to Day 8 post-dose
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Pui Leung, MBChB, Quotient Clinical
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2016
Primärt slutförande (Faktisk)
1 september 2016
Avslutad studie (Faktisk)
1 september 2016
Studieregistreringsdatum
Först inskickad
6 december 2016
Först inskickad som uppfyllde QC-kriterierna
23 februari 2017
Första postat (Faktisk)
1 mars 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CORT125134-121
- 2016-000668-41 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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