- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04795479
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
36
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
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.
|
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Other Names:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
January 22, 2021
Primary Completion (Actual)
May 17, 2021
Study Completion (Actual)
July 13, 2021
Study Registration Dates
First Submitted
January 29, 2021
First Submitted That Met QC Criteria
March 11, 2021
First Posted (Actual)
March 12, 2021
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 10, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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