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

10. September 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

36

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Missouri
      • Springfield, Missouri, Vereinigte Staaten, 65802
        • Single Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: 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.
Arzneimittel: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Andere Namen:
  • CORT125134
Arzneimittel: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Arzneimittel: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change from Baseline in Cardiac QTcF
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Day 6 of each treatment period (up to 51 days)
Up to Day 6 of each treatment period (up to 51 days)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Corcept Therapeutics

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Januar 2021

Primärer Abschluss (Tatsächlich)

17. Mai 2021

Studienabschluss (Tatsächlich)

13. Juli 2021

Studienanmeldedaten

Zuerst eingereicht

29. Januar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. März 2021

Zuerst gepostet (Tatsächlich)

12. März 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. September 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2021

Zuletzt verifiziert

1. September 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CORT125134-130

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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