HealthyPhase 1NCT03508635

CORT125134 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

A Phase 1 study testing CORT125134, Mifepristone and Prednisone in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125134 and its active metabolite CORT125201 after single and multiple ascending oral doses of CORT125134 in healthy participants. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: CORT125134, Mifepristone and Prednisone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2014to Dec 2015
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provide written informed consent
Weight <= 102 kilogram (kg); body mass index (BMI) 18-30 kg/meter squared
Morning serum cortisol in reference range
Willing and able to communicate, participate in the whole study and to abide by study restrictions including use of contraception

Who cannot join

Participation in any clinical research study, received treatment with any investigational drug or device, or donated blood within the previous 3 months
Has a history of alcoholism, substance abuse, or drug abuse within 1 year; positive screen for alcohol or drugs of abuse
Current smokers, smoked and/or used tobacco and/or nicotine-containing products within 6 months, or positive screen for carbon monoxide
Females of childbearing potential, pregnant or breastfeeding, and/or with a positive pregnancy test
Has a condition that could be aggravated by glucocorticoid blockade or activation
Has clinically relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead electrocardiogram (ECG)
Has history of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, chronic respiratory, gastrointestinal or neurological disease
Has used systemic glucocorticoids within 12 months

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS

Other trials in United Kingdom

About this study

Official title: 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

Read the detailed description

This is a 3-part, single-center study of single and multiple ascending doses of CORT125134 in healthy participants.

Part I is a single dose study. Initially, participants will be enrolled sequentially into 1 of up to 6 cohorts, each containing 10 participants, in a double-blind, randomized, placebo-controlled assessment of single-ascending doses (SAD) of CORT125134. Within each cohort, 8 participants will be randomly assigned to receive a single dose of CORT125134, and 2 participants will be randomly assigned to receive a single dose of matching placebo. Thereafter, Cohort 7 will be a food-effect cohort, in which all 8 participants will receive a single dose of CORT125134 after a high-fat breakfast (open label). Cohorts 8 and 9 will be pharmacological effect cohorts, in each of which 10 participants will receive a challenge agent (prednisone, 25 mg) alone on Day -19; with an active comparator (mifepristone, 600 mg) on Day -12, and with CORT125134 on Day 1 in an open-label single sequence crossover design. Pharmacological effects will be explored by measuring effects on peripheral blood eosinophil, lymphocyte and neutrophil counts, serum osteocalcin, assay of messenger ribonucleic acid (mRNA) expression of FK506 Binding Protein 5 (FKBP5) and Glucocorticoid-induced Leucine Zipper (GILZ) in whole blood (proof of pharmacological effect Cohort 8) and by measuring effects on oral glucose tolerance (proof of concept Cohort 9).

Part 2 and 3 will be double-blind, randomized, placebo-controlled assessments of multiple oral ascending doses (MAD) of CORT125134. Participants will be enrolled sequentially into 1 of up to 4 cohorts (Cohorts 10-13), each containing 12 participants. Within each cohort, 9 participants will be randomly assigned to receive CORT125134 and 3 participants to receive matching placebo daily for 14 days (Days 1-14). The effects of CORT125134 on response to prednisone challenge will be additionally explored in Cohorts 12 and 13 in a single sequence crossover, with prednisone being given alone on Day -5 and in combination with CORT125134 or placebo on Day 14.

Throughout the study, routine safety tests and assessments of PK (CORT125134 and CORT125201) will be performed, and changes in serum cortisol and plasma adrenocorticotrophic hormone (ACTH) measured.

Conditions: Healthy
Being tested: CORT125134, Matching Placebo of CORT125134, Mifepristone, Prednisone, Glucose
Keywords: Glucocorticoid receptor; antagonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CORT125134Drug
Oral capsules
Matching Placebo of CORT125134Drug
Placebo
MifepristoneDrug
Active comparator
PrednisoneDrug
Challenge agent
GlucoseDrug

Study groups in NCT03508635
Study group	Role	What they receive
SAD Cohorts 1 through 6	Experimental	Participants will receive single doses of 5 mg up to 400 mg of CORT125134 (capsule) in a dose escalation format. The doses selected will be subject to amendment based on emerging data. Receives: Drug: CORT125134
SAD Cohorts 1 through 6 Placebo	Placebo comparator	Participants will receive single doses of Matching Placebo of CORT125134 (capsule). Receives: Drug: Matching Placebo of CORT125134
Food Effect Cohort 7	Experimental	Participants will receive a single dose of CORT125134 (capsule) with a standard high fat breakfast. The dose will be chosen such that it has been previously administered in a prior SAD cohort. Receives: Drug: CORT125134
Pharmacological Effect Cohort 8	Experimental	Participants will receive a single dose of 25 mg of prednisone on Day -19; a single dose of 25 mg prednisone and 600 mg of mifepristone on Day -12; and a single dose of 25 mg prednisone and a single dose of CORT125134 on Day 1. The dose of CORT125134 will be chosen such that it has been previously administered in a prior SAD cohort. Receives: Drug: CORT125134; Drug: Mifepristone; Drug: Prednisone
Proof of Concept (POC) Cohort 9	Experimental	Participants will receive a single dose of 25 mg of prednisone on Day -19; a single dose of 25 mg of prednisone and 600 mg of mifepristone on Day -12; and a single dose of 25 mg prednisone and a single dose of CORT125134 on Day 1. An oral glucose tolerance test will be administered on each study day. The dose of CORT125134 will be chosen such that it has been previously administered in a prior SAD cohort. Receives: Drug: CORT125134; Drug: Mifepristone; Drug: Prednisone; Drug: Glucose
MAD Cohorts 10 and 11	Experimental	Participants will receive the selected dose of CORT125134 (capsule) following receipt of data from Cohorts 1-9 up to a maximum frequency of twice a day for a total of 14 days. Receives: Drug: CORT125134
MAD Cohorts 10 and 11 Placebo	Placebo comparator	Participants will receive Matching Placebo of CORT125134 (capsule) up to a maximum frequency of twice a day for a total of 14 days. Receives: Drug: Matching Placebo of CORT125134
MAD of PoPE Cohorts 12 and 13	Experimental	Proof of Pharmacological Effect (PoPE+POC). Participants will receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day -5. Participants will then receive the selected dose of CORT125134 (capsule) for a total of 13 days. Participants may either receive a higher dose level than previously administered or a repeat of a dose level given in 1 of the previous 2 MAD Cohorts. Participants will then receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day 14. Receives: Drug: CORT125134; Drug: Prednisone; Drug: Glucose
MAD of PoPE Cohort 12 and 13 Placebo	Placebo comparator	Participants will receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day -5. Participants will then receive the Matching Placebo of CORT125134 (capsule) for a total of 13 days. Participants will then receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day 14. Receives: Drug: Matching Placebo of CORT125134; Drug: Prednisone; Drug: Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events (AEs) (Safety and Tolerability) of CORT125134
Measured: Single dose Cohorts 1-9 Day 1 to Day 15; MAD Cohorts 10-13 Day 1 to Day 28/Day 24 (Cohort 13)

Secondary outcomes (18)

QT internal corrected for heart rate using Fridericia's formula (QTcF) exposure-response analysis
Measured: SAD Cohorts 1-6: Pre dose through 24 hours post dose; MAD Cohorts: Pre first dose through 24 hours post final dose of Investigational Medicinal Product (IMP)
CORT125134 Pharmacokinetic (PK) of total lag time (Tlag)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125134 PK of peak plasma concentration (Cmax)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125134 PK of time to reach maximum observed concentration (Tmax)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts 10-12 Day 1 to Day 28/24 (Cohort 13)
CORT125134 PK of area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK of peak plasma concentration (Cmax)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK time Lag (Tlag)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK of time to reach maximum observed concentration (Tmax)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK of area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Measured: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Say 28/24 (Cohort 13)
Eosinophil count
Measured: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Lymphocyte count
Measured: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Neutrophil count
Measured: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Osteocalcin
Measured: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
FKBP5 expression
Measured: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Glucocorticoid-induced leucine zipper (GILZ) expression
Measured: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Glucose tolerance
Measured: Single dose Cohort 9 Days -19 to Day 2; MAD Cohort 13 Days -5 to Day 15
Serum cortisol
Measured: SAD Cohorts 1-6: Pre dose to Day 15; MAD Cohorts 10-11: Pre dose to Day 28
Plasma adrenocorticotrophic hormone (ACTH)
Measured: SAD Cohorts 1-6: Pre dose to Day 15; MAD Cohorts 10-11: Pre dose to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2015

First posted26 Apr 2018
Study startSep 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03508635
Sponsor's protocol ID: CORT125134-120
Other IDs: 2014-001951-21, 2014
Status last verified: Aug 2019
First submitted: 21 Feb 2017
Last updated: 9 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Hunt H, Donaldson K, Strem M, Zann V, Leung P, Sweet S, Connor A, Combs D, Belanoff J. Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study. Clin Pharmacol Drug Dev. 2018 May;7(4):408-421. doi: 10.1002/cpdd.389. Epub 2017 Oct 2.
PubMed 28967708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03508635
Acronym / sponsor ID: CORT125134-120
Conditions: Healthy
Keywords: Glucocorticoid receptor; antagonist
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Corcept TherapeuticsIndustry (pharma, biotech, devices)
Study start: Sep 2014 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 26 Apr 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a 3-part, single-center study of single and multiple ascending doses of CORT125134 in healthy participants.

Throughout the study, routine safety tests and assessments of PK (CORT125134 and CORT125201) will be performed, and changes in serum cortisol and plasma adrenocorticotrophic hormone (ACTH) measured.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
SAD Cohorts 1 through 6	Experimental	Drug: CORT125134Participants will receive single doses of 5 mg up to 400 mg of CORT125134 (capsule) in a dose escalation format. The doses selected will be subject to amendment based on emerging data.
SAD Cohorts 1 through 6 Placebo	Placebo comparator	Drug: Matching Placebo of CORT125134Participants will receive single doses of Matching Placebo of CORT125134 (capsule).
Food Effect Cohort 7	Experimental	Drug: CORT125134Participants will receive a single dose of CORT125134 (capsule) with a standard high fat breakfast. The dose will be chosen such that it has been previously administered in a prior SAD cohort.
Pharmacological Effect Cohort 8	Experimental	Drug: CORT125134, Drug: Mifepristone, Drug: PrednisoneParticipants will receive a single dose of 25 mg of prednisone on Day -19; a single dose of 25 mg prednisone and 600 mg of mifepristone on Day -12; and a single dose of 25 mg prednisone and a single dose of CORT125134 on Day 1. The dose of CORT125134 will be chosen such that it has been previously administered in a prior SAD cohort.
Proof of Concept (POC) Cohort 9	Experimental	Drug: CORT125134, Drug: Mifepristone, Drug: Prednisone, Drug: GlucoseParticipants will receive a single dose of 25 mg of prednisone on Day -19; a single dose of 25 mg of prednisone and 600 mg of mifepristone on Day -12; and a single dose of 25 mg prednisone and a single dose of CORT125134 on Day 1. An oral glucose tolerance test will be administered on each study day. The dose of CORT125134 will be chosen such that it has been previously administered in a prior SAD cohort.
MAD Cohorts 10 and 11	Experimental	Drug: CORT125134Participants will receive the selected dose of CORT125134 (capsule) following receipt of data from Cohorts 1-9 up to a maximum frequency of twice a day for a total of 14 days.
MAD Cohorts 10 and 11 Placebo	Placebo comparator	Drug: Matching Placebo of CORT125134Participants will receive Matching Placebo of CORT125134 (capsule) up to a maximum frequency of twice a day for a total of 14 days.
MAD of PoPE Cohorts 12 and 13	Experimental	Drug: CORT125134, Drug: Prednisone, Drug: GlucoseProof of Pharmacological Effect (PoPE+POC). Participants will receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day -5. Participants will then receive the selected dose of CORT125134 (capsule) for a total of 13 days. Participants may either receive a higher dose level than previously administered or a repeat of a dose level given in 1 of the previous 2 MAD Cohorts. Participants will then receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day 14.
MAD of PoPE Cohort 12 and 13 Placebo	Placebo comparator	Drug: Matching Placebo of CORT125134, Drug: Prednisone, Drug: GlucoseParticipants will receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day -5. Participants will then receive the Matching Placebo of CORT125134 (capsule) for a total of 13 days. Participants will then receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day 14.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Provide written informed consent
Weight <= 102 kilogram (kg); body mass index (BMI) 18-30 kg/meter squared
Morning serum cortisol in reference range
Willing and able to communicate, participate in the whole study and to abide by study restrictions including use of contraception

Key exclusion criteria (8 listed)

Participation in any clinical research study, received treatment with any investigational drug or device, or donated blood within the previous 3 months
Has a history of alcoholism, substance abuse, or drug abuse within 1 year; positive screen for alcohol or drugs of abuse
Current smokers, smoked and/or used tobacco and/or nicotine-containing products within 6 months, or positive screen for carbon monoxide
Females of childbearing potential, pregnant or breastfeeding, and/or with a positive pregnancy test
Has a condition that could be aggravated by glucocorticoid blockade or activation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CORT125134Oral capsules	Drug	Food Effect Cohort 7, MAD Cohorts 10 and 11, MAD of PoPE Cohorts 12 and 13, Pharmacological Effect Cohort 8, Proof of Concept (POC) Cohort 9, SAD Cohorts 1 through 6
Matching Placebo of CORT125134Placebo	Drug	MAD Cohorts 10 and 11 Placebo, MAD of PoPE Cohort 12 and 13 Placebo, SAD Cohorts 1 through 6 Placebo
MifepristoneActive comparator	Drug	Pharmacological Effect Cohort 8, Proof of Concept (POC) Cohort 9
PrednisoneChallenge agent	Drug	MAD of PoPE Cohort 12 and 13 Placebo, MAD of PoPE Cohorts 12 and 13, Pharmacological Effect Cohort 8, Proof of Concept (POC) Cohort 9
Glucose	Drug	MAD of PoPE Cohort 12 and 13 Placebo, MAD of PoPE Cohorts 12 and 13, Proof of Concept (POC) Cohort 9

Primary outcome

Incidence of Treatment-Emergent Adverse Events (AEs) (Safety and Tolerability) of CORT125134
Time frame: Single dose Cohorts 1-9 Day 1 to Day 15; MAD Cohorts 10-13 Day 1 to Day 28/Day 24 (Cohort 13)

18 secondary outcomes

QT internal corrected for heart rate using Fridericia's formula (QTcF) exposure-response analysis
Time frame: SAD Cohorts 1-6: Pre dose through 24 hours post dose; MAD Cohorts: Pre first dose through 24 hours post final dose of Investigational Medicinal Product (IMP)
CORT125134 Pharmacokinetic (PK) of total lag time (Tlag)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125134 PK of peak plasma concentration (Cmax)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125134 PK of time to reach maximum observed concentration (Tmax)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts 10-12 Day 1 to Day 28/24 (Cohort 13)
CORT125134 PK of area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK of peak plasma concentration (Cmax)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK time Lag (Tlag)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK of time to reach maximum observed concentration (Tmax)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Day 28/24 (Cohort 13)
CORT125201 PK of area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Time frame: Single dose Cohorts Day 1 to Day 15; MAD Cohorts Day 1 to Say 28/24 (Cohort 13)
Eosinophil count
Time frame: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Lymphocyte count
Time frame: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Neutrophil count
Time frame: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Osteocalcin
Time frame: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
FKBP5 expression
Time frame: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Glucocorticoid-induced leucine zipper (GILZ) expression
Time frame: Single dose Cohort 8 Days -19 to Day 2; MAD Cohorts 12 and 13 Days -5 to Day 15
Glucose tolerance
Time frame: Single dose Cohort 9 Days -19 to Day 2; MAD Cohort 13 Days -5 to Day 15
Serum cortisol
Time frame: SAD Cohorts 1-6: Pre dose to Day 15; MAD Cohorts 10-11: Pre dose to Day 28
Plasma adrenocorticotrophic hormone (ACTH)
Time frame: SAD Cohorts 1-6: Pre dose to Day 15; MAD Cohorts 10-11: Pre dose to Day 28

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
Background: PubMed 28967708Hunt H, Donaldson K, Strem M, Zann V, Leung P, Sweet S, Connor A, Combs D, Belanoff J. Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study. Clin Pharmacol Drug Dev. 2018 May;7(4):408-421. doi: 10.1002/cpdd.389. Epub 2017 Oct 2.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pui Leung principal investigator

Quotient Clinical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CORT125134, Mifepristone and Prednisone in people with Healthy, run by Corcept Therapeutics at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (AEs) (Safety and Tolerability) of CORT125134 (time frame: Single dose Cohorts 1-9 Day 1 to Day 15; MAD Cohorts 10-13 Day 1 to Day 28/Day 24 (Cohort 13)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03508635, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.