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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. Mai 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

24

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
    • Minnesota
      • Saint Paul, Minnesota, Vereinigte Staaten, 55114
        • Prism Clinical Research

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

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Arzneimittel: 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.
Arzneimittel: 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
Experimental: 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.
Arzneimittel: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The Effect of Vapendavir on the PK Profile of Midazolam
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

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

Sponsor

Biota Scientific Management Pty Ltd

Ermittler

  • Hauptermittler: Mark Matson, MD, Prism Clinical Research

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

1. Mai 2014

Primärer Abschluss (Tatsächlich)

1. Juni 2014

Studienabschluss (Tatsächlich)

1. Juni 2014

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2014

Zuerst gepostet (Schätzen)

30. Juli 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2018

Zuletzt verifiziert

1. Mai 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BTA798-102

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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