T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers

September 10, 2021 updated by: Corcept Therapeutics

A Randomized, Partial Double-Blind, Placebo- and Positive- Controlled, Multiple-Dose, 4-Way Crossover, Thorough QT/QTc (TQT) Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers

This dedicated T/QT study will investigate the effect of relacorilant on cardiac repolarization in healthy participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This four-period crossover study with 12 treatment sequences includes relacorilant administered at therapeutic (400 mg once daily [QD]) and supra-therapeutic (800 mg QD) doses, placebo for relacorilant as a negative control, and oral moxifloxacin as a positive control. The positive control will serve to determine the sensitivity of the assay to detect small increases from baseline in the QTc interval. Each of the four treatment periods will last 5 days with a washout of at least 10 days between periods. Relacorilant and placebo to relacorilant will be administered double-blind; moxifloxacin will be administered open label.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Single Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant with a BMI ≥18.0 kg/m^2 and ≤30.0 kg/m^2 at screening
  • No clinically significant abnormal findings with the physical examination, medical/surgical/medication history, vital signs, or clinical laboratory assessments and adequate cardiac conduction by electrocardiogram (ECG) without evidence of first-, second- or third-degree atrioventricular block
  • Female participants of childbearing potential with a negative serum pregnancy test at screening and urine pregnancy test on Day -1 of Period 1
  • All male participants agree to use condom to prevent exposure to partner; male participants with female partner of childbearing potential to use a second method of contraception
  • Female participants of childbearing potential agree to use the highly effective contraception of low user dependency
  • Participant is willing and able to comply with all study procedures and restrictions
  • Participant understands the study procedures and agrees to participate by providing written informed consent.

Exclusion Criteria:

  • Participant with history or presence of any clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, endocrine, immunologic, dermatologic, neurological, psychiatric disease or disorder or any uncontrolled medical illness which in the opinion of the investigator would jeopardize the safety of the participant, interfere with study assessments, or impact the validity of the study results
  • Participant with a history or family history of additional risk factors for Torsade de Pointe (TdP)
  • Participant with a marked prolongation of ECG intervals, including QTcF >450 milliseconds (msec), PR >200 msec, or QRS >120 msec
  • Participant with resting heart rate of <45beats per minute (bpm) or >100 bpm
  • Participant with clinically significant abnormal ECG results
  • Participant who uses medications that could prolong the QT/QTc interval
  • Participant taking medications/dietary supplements that are highly dependent on cytochrome (CYP)3A for clearance and cannot undergo dose modification upon co-administration with strong CYP3A inhibitors
  • Participant using any strong CYP3A inhibitor/inducer or any other medications prohibited per protocol
  • Participant who is receiving testosterone within 40 days prior to study start
  • Participant with a positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, or hepatitis C antibody
  • Participant with a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19)
  • Participant who has travelled abroad within 3 months prior to the screening visit or plans to travel abroad during the study
  • Participant who has had a major surgery within the last 28 days prior to Screening
  • Participant who received any investigational product within 30 days prior to Screening
  • Participant who has a known or suspected allergy, or sensitivity to study products, or any of its ingredient(s), or to moxifloxacin
  • Intolerance to repeated venipuncture or inability to swallow capsules
  • Donation of blood within 56 days or plasma within 14 days prior to Screening or plans to donate during the entire study period
  • Positive alcohol test and/or positive drugs of abuse screen or reports of a history of substance or alcohol abuse within 1 year prior to Screening
  • Female participant who is pregnant, breastfeeding, or is planning to become pregnant during the entire study period
  • Male participant with pregnant partner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Sequence 1
Participants will receive relacorilant 400 mg once daily (QD) for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 2
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 3
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 4
Participants will receive relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 5
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 6
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 7
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 8
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 9
Participants will receive placebo to relacorilant QD for 5 days in Period 1, followed by relacorilant 400 mg QD for 5 days in Period 2, followed by relacorilant 800 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 10
Participants will receive relacorilant 400 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 2, followed by placebo to relacorilant QD for 5 days in Period 3, followed by relacorilant 800 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 11
Participants will receive relacorilant 800 mg QD for 5 days in Period 1, followed by placebo to relacorilant QD for 5 days in Period 2, followed by placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 3, followed by relacorilant 400 mg QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Experimental: Treatment Sequence 12
Participants will receive placebo to relacorilant QD for 4 days and moxifloxacin 400 mg on Day 5 in Period 1, followed by relacorilant 800 mg QD for 5 days in Period 2, followed by relacorilant 400 mg QD for 5 days in Period 3, followed by placebo to relacorilant QD for 5 days in Period 4. Treatment periods will be separated by a washout of at least 10 days.
Drug: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
  • CORT125134
Drug: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Drug: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Cardiac QTcF
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Change from Baseline in Heart Rate (HR)
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Placebo-corrected Change from Baseline in HR
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Change from Baseline in Cardiac PR Interval
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Placebo-corrected Change from Baseline in Cardiac PR Interval
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Change from Baseline in Cardiac QRS Intervals
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Placebo-corrected Change from Baseline in Cardiac QRS Intervals
Time Frame: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
Number of Participants with a Categorical Outlier in QTcF
Time Frame: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Number of Participants with a Categorical Outlier in HR
Time Frame: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Number of Participants with a Categorical Outlier in PR Interval
Time Frame: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Number of Participants with a Categorical Outlier in QRS Intervals
Time Frame: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Number of Participants with a Treatment-emergent Change of T-wave Morphology
Time Frame: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Number of Participants with a Treatment-emergent Presence of U-waves
Time Frame: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
Maximum Plasma Concentration (Cmax) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Time Frame: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Time to Reach Cmax (Tmax) of Plasma Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Time Frame: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Minimum Plasma Concentration (Cmin) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Time Frame: Before dosing on Day 5 of each treatment period
Before dosing on Day 5 of each treatment period
Area Under the Plasma-concentration Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Time Frame: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Area Under the Plasma-concentration Curve from Time Zero to 24 Hours Postdose (AUC0-24) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
Time Frame: Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Before dosing and at 0.5, 1, 1,5, 2, 3, 4, 6, 8, 12, 16, and 24 hours after dosing on Day 1 and 5 in each treatment period
Number of Participants with One or More Adverse Events
Time Frame: Up to Day 6 in each treatment period (up to 51 days)
Up to Day 6 in each treatment period (up to 51 days)
Number of Participants Discontinued From Study Treatment due to an Adverse Event
Time Frame: Up to Day 6 of each treatment period (up to 51 days)
Up to Day 6 of each treatment period (up to 51 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CORT125134-130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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