T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
2021년 9월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
36
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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Springfield, Missouri, 미국, 65802
- Single Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
|
실험적: 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
다른 이름들:
Placebo to relacorilant capsule by mouth once daily
Moxifloxacin 400 mg tablet by mouth
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from Baseline in Cardiac QTcF
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Heart Rate (HR)
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in HR
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Cardiac PR Interval
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in Cardiac PR Interval
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Change from Baseline in Cardiac QRS Intervals
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Placebo-corrected Change from Baseline in Cardiac QRS Intervals
기간: Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Before dosing (Baseline) through 24 hours after the final dose on Day 5 in each treatment period
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Number of Participants with a Categorical Outlier in QTcF
기간: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Categorical Outlier in HR
기간: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Categorical Outlier in PR Interval
기간: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Categorical Outlier in QRS Intervals
기간: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Treatment-emergent Change of T-wave Morphology
기간: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Number of Participants with a Treatment-emergent Presence of U-waves
기간: Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Up to Day 6 in each treatment period (through 24 hours after the final dose on Day 5 in each treatment period)
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Maximum Plasma Concentration (Cmax) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
기간: 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
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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
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Time to Reach Cmax (Tmax) of Plasma Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
기간: 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
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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
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Minimum Plasma Concentration (Cmin) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
기간: Before dosing on Day 5 of each treatment period
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Before dosing on Day 5 of each treatment period
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Area Under the Plasma-concentration Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
기간: 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
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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
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Area Under the Plasma-concentration Curve from Time Zero to 24 Hours Postdose (AUC0-24) of Relacorilant, Metabolites of Relacorilant, and Moxifloxacin
기간: 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
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Number of Participants with One or More Adverse Events
기간: Up to Day 6 in each treatment period (up to 51 days)
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Up to Day 6 in each treatment period (up to 51 days)
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Number of Participants Discontinued From Study Treatment due to an Adverse Event
기간: Up to Day 6 of each treatment period (up to 51 days)
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Up to Day 6 of each treatment period (up to 51 days)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 1월 22일
기본 완료 (실제)
2021년 5월 17일
연구 완료 (실제)
2021년 7월 13일
연구 등록 날짜
최초 제출
2021년 1월 29일
QC 기준을 충족하는 최초 제출
2021년 3월 11일
처음 게시됨 (실제)
2021년 3월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 10일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CORT125134-130
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Relacorilant에 대한 임상 시험
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Corcept Therapeutics완전한코르티솔혈증미국, 불가리아, 독일, 이스라엘, 이탈리아, 폴란드, 루마니아, 스페인, 오스트리아
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University of ChicagoNational Cancer Institute (NCI); Corcept Therapeutics완전한
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Corcept Therapeutics모집하지 않고 적극적으로쿠싱 증후군미국, 독일, 이스라엘, 이탈리아, 네덜란드, 루마니아, 스페인, 폴란드, 캐나다, 오스트리아
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Corcept Therapeutics완전한재발성 나팔관 암종 | 재발성 원발성 복막암 | 재발성 난소암미국, 벨기에, 캐나다, 이탈리아, 스페인
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Corcept Therapeutics모병복막 신생물 | 난소 암 | 나팔관암 | 자궁내막암벨기에, 스페인, 미국, 프랑스, 이탈리아, 폴란드, 독일, 대한민국
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Corcept Therapeutics모병
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University of Chicago모병