Evidence map›Paper›PMID 28967708›Full record

Trial reportClinical pharmacology in drug development2018

Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study.

Hazel Hunt, Kirsteen Donaldson, Mark Strem, Vanessa Zann, Pui Leung, Suzanne Sweet, Alyson Connor, Dan Combs, Joseph Belanoff

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03508635 (A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03508635 phase1completednot on this map

A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects

TypeinterventionalSponsorCorcept TherapeuticsRan2014 to 2015Enrolled130ConditionsHealthyArmsCORT125134, Matching Placebo of CORT125134, Mifepristone, Prednisone, Glucose
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  12. New Trends in Treating Cushing's Disease.TouchREVIEWS in endocrinology · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Hazel HuntCorcept Therapeutics, Menlo Park, CA, USA.
Kirsteen DonaldsonJade Consultants (Cambridge) Ltd, Cambridge, UK.
Mark StremCorcept Therapeutics, Menlo Park, CA, USA.
Vanessa ZannQuotient Clinical, Nottingham, UK.
Pui LeungQuotient Clinical, Nottingham, UK.
Suzanne SweetQuotient Clinical, Nottingham, UK.
Alyson ConnorQuotient Clinical, Nottingham, UK.
Dan CombsCombs Consulting Service, Mountain View, CA, USA.
Joseph BelanoffCorcept Therapeutics, Menlo Park, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CORT125134 is an orally active, high-affinity, selective antagonist of the glucocorticoid receptor that is being developed for indications that may benefit from the modulation of cortisol activity. This first-in-human study was conducted to evaluate the dose-related safety, tolerability, pharmacokinetics and pharmacological effects of CORT125134 and its active metabolite CORT125201. Eighty-one healthy male or female subjects received a single dose of 5 to 500 mg CORT125134 or matching placebo across 9 cohorts; 1 cohort received 150 mg CORT125134 after a high-fat breakfast; and 46 subjects received 50 to 500 mg CORT125134 or matching placebo once daily for up to 14 days across 4 cohorts. CORT125134 was well tolerated at doses up to 250 mg per day for 14 days. CORT125134 was absorbed rapidly and eliminated with a mean half-life ranging from 11 to 19 hours. Steady state was achieved by day 7. Exposure increased in a greater than proportional manner, particularly at lower doses. Exposure to CORT125201 at steady state was less than 5% that of parent CORT125134. Evidence for the desired pharmacological effect (glucocorticoid receptor antagonism) was demonstrated by the ability of CORT125134 to prevent several effects of the glucocorticoid receptor agonist prednisone.

Indexed as

Administration, OralArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHalf-LifeHealthy VolunteersHumansIsoquinolinesMalePyrazolesPyridinesReceptors, GlucocorticoidSmall Molecule LibrariesIsoquinolinesPyrazolesPyridinesReceptors, GlucocorticoidrelacorilantSmall Molecule LibrariesCORT125134Cushing syndromeFirst-in-HumanGlucocorticoidPharmacological effect

Identifiers

PMID28967708
PMCPMC5947602

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.