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

NCT04795479 | Completed Phase 1 FDA Drug

• 1 other identifier: CORT125134-130
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)

  Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period

Secondary Outcomes (20)

• Change from Baseline in Cardiac QTcF

  Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period

• Change from Baseline in Heart Rate (HR)

  Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period

• Placebo-corrected Change from Baseline in HR

  Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period

• Change from Baseline in Cardiac PR Interval

  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

  Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period

Study Arms (12)

Treatment Sequence 1

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 2

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 3

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 4

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 5

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 6

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 7

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 8

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 9

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 10

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 11

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Treatment Sequence 12

EXPERIMENTAL

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; Drug: Placebo to relacorilant; Drug: Moxifloxacin

Interventions

Relacorilant DRUG

Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily

Also known as: CORT125134

Treatment Sequence 1; Treatment Sequence 10; Treatment Sequence 11; Treatment Sequence 12; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6; Treatment Sequence 7; Treatment Sequence 8; Treatment Sequence 9

Placebo to relacorilant DRUG

Placebo to relacorilant capsule by mouth once daily

Treatment Sequence 1; Treatment Sequence 10; Treatment Sequence 11; Treatment Sequence 12; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6; Treatment Sequence 7; Treatment Sequence 8; Treatment Sequence 9

Moxifloxacin DRUG

Moxifloxacin 400 mg tablet by mouth

Treatment Sequence 1; Treatment Sequence 10; Treatment Sequence 11; Treatment Sequence 12; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6; Treatment Sequence 7; Treatment Sequence 8; Treatment Sequence 9

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Single Site

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Interventions

relacorilant; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph Custodio, PhD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 12, 2021
• Study Start: January 22, 2021
• Primary Completion: May 17, 2021
• Study Completion: July 13, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)