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

10 settembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

36

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Missouri
      • Springfield, Missouri, Stati Uniti, 65802
        • Single Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth
Sperimentale: 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.
Droga: Relacorilant
Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
Altri nomi:
  • CORT125134
Droga: Placebo to relacorilant
Placebo to relacorilant capsule by mouth once daily
Droga: Moxifloxacin
Moxifloxacin 400 mg tablet by mouth

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Placebo-corrected Change from Baseline in Cardiac QT Interval Corrected by Fridericia's Formula (QTcF)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Change from Baseline in Cardiac QTcF
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to Day 6 of each treatment period (up to 51 days)
Up to Day 6 of each treatment period (up to 51 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Corcept Therapeutics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 gennaio 2021

Completamento primario (Effettivo)

17 maggio 2021

Completamento dello studio (Effettivo)

13 luglio 2021

Date di iscrizione allo studio

Primo inviato

29 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

11 marzo 2021

Primo Inserito (Effettivo)

12 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2021

Ultimo verificato

1 settembre 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CORT125134-130

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sedi

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