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A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

29 maggio 2018 aggiornato da: Biota Scientific Management Pty Ltd

A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers

The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

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
    • Minnesota
      • Saint Paul, Minnesota, Stati Uniti, 55114
        • Prism Clinical Research

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

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening;
  • Capable of giving written informed consent;
  • Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
  • Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
  • Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam/gel/film/cream/suppository); and
  • Female subjects must not be breastfeeding or pregnant.

Exclusion Criteria:

  • Positive results for Hepatitis B, Hepatitis C, or HIV;
  • Frequent use (defined as > 5 times/day) of tobacco products, including cigarettes, cigars, chewing tobacco;
  • A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;
  • Current or recent respiratory infection (defined as within 14 days of first study visit participation)
  • Presence or history of significant allergy;
  • Clinically significant abnormalities noted on ECG;
  • Screening vital signs representing sustained elevated systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure <55 mmHg or >90 mmHg.
  • Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;
  • Safety laboratory abnormalities noted at screening which are clinically significant
  • Current or defined history of abuse of alcohol or illicit drugs;
  • A positive pregnancy test at screening;
  • Poor vein access or fear of venipuncture or sight of blood; and
  • Regular consumption of alcohol defined as either > 2 units (glass or shot) of alcoholic beverages per day or > 14 units per week.

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: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Vapendavir 528 mg QD
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
Droga: Midazolam 5mg Syrup

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

  • On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
  • On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.
Droga: Vapendavir 528 mg QD
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
Sperimentale: Vapendavir 264 mg BID
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
Droga: Midazolam 5mg Syrup

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

  • On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
  • On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.
Droga: Vapendavir 264 mg BID
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Effect of Vapendavir on the PK Profile of Midazolam
Lasso di tempo: End of Study (up to 46 weeks in duration)

To evaluate the effect of vapendavir daily dose of 264 mg BID on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:

  • for midazolam including maximum observed plasma concentration (Cmax)
  • time at which Cmax was observed (Tmax)
  • plasma concentration at the end of the dosing interval (Ctau)
  • area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
  • area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
  • area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
  • elimination half-life (t1/2)
  • apparent oral clearance (CL/F)
  • apparent oral volume of distribution (Vz/F).
End of Study (up to 46 weeks in duration)
The Effect of Vapendavir on the PK Profile of Midazolam
Lasso di tempo: End of Study (up to 46 weeks in duration)

To evaluate the effect of vapendavir daily dose of 528 mg QD on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:

  • for midazolam including maximum observed plasma concentration (Cmax)
  • time at which Cmax was observed (Tmax)
  • plasma concentration at the end of the dosing interval (Ctau)
  • area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
  • area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
  • area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
  • elimination half-life (t1/2)
  • apparent oral clearance (CL/F)
  • apparent oral volume of distribution (Vz/F).
End of Study (up to 46 weeks in duration)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
Lasso di tempo: End of Study (up to 46 weeks in duration)

To evaluate whether the PK profile of vapendavir, is affected by the presence of midazolam, a strong CYP3A4 substrate. This outcome will be evaluated through a series of analyses of PK parameters for vapendavir including:

  • maximum observed plasma concentration (Cmax)
  • time at which Cmax was observed (Tmax)
  • plasma concentration at the end of the dosing interval (Ctau)
  • area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-last)
  • area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUC0-tau)
  • area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
  • elimination half-life (t1/2)
  • apparent oral clearance (CL/F)
  • apparent oral volume of distribution (Vz/F).
End of Study (up to 46 weeks in duration)
Assess the Safety of Vapendavir
Lasso di tempo: End of Study (up to 46 weeks in duration
To evaluate the safety of vapendavir. This will be accomplished by assessing adverse events, clinical laboratory tests (including blood chemistry, hematology with differential and urinalysis), physical exams, ECG assessments, vital sign assessments and concomitant medications.
End of Study (up to 46 weeks in duration

Collaboratori e investigatori

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

Sponsor

Biota Scientific Management Pty Ltd

Investigatori

  • Investigatore principale: Mark Matson, MD, Prism Clinical Research

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

1 maggio 2014

Completamento primario (Effettivo)

1 giugno 2014

Completamento dello studio (Effettivo)

1 giugno 2014

Date di iscrizione allo studio

Primo inviato

27 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2014

Primo Inserito (Stima)

30 luglio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 maggio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BTA798-102

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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