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A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

12. Mai 2017 aktualisiert von: GlaxoSmithKline

A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.

Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.

Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.

Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

54

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

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 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Exclusion Criteria:

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen.
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day

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: Einzelgruppenzuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Part 1: Cohort 1a
Single IV dose of GSK2862277 as a continuous infusion over 2 hours.
Arzneimittel: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 1: Cohort 1b
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.
Arzneimittel: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 1: Cohort 1c
Single IV dose of GSK2862277 as a continuous infusion over 3 hours.
Arzneimittel: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 2: Cohort 2a GSK2862277
Single IV dose of GSK2862277 as a continuous infusion over 1 hour.
Arzneimittel: Single IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 2: Cohort 2a Placebo
Matching placebo will be administered as a continuous IV infusion over 1 hour.
Arzneimittel: Matching placebo single dose IV infusion
Matching placebo solution available for IV administration.
Experimental: Part 2: Cohort 2b GSK2862277
Single IH dose of GSK2862277.
Arzneimittel: Single IH dose of GSK2862277
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
Experimental: Part 2: Cohort 2b Placebo
Matching placebo will be administered.
Arzneimittel: Matching placebo single dose IH
Matching placebo nebulised solution available for IH administration.
Experimental: Part 3: Cohort 3a GSK2862277
IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days.
Arzneimittel: Repeat IV dose of GSK2862277
GSK2862277 solution available in a 40 mg vial for IV administration.
Experimental: Part 3: Cohort 3a Placebo
Matching placebo will be administered as IV infusion over 1 hour daily for 5 days.
Arzneimittel: Matching placebo repeat dose IV infusion
Matching placebo solution available for IV administration.
Experimental: Part 3: Cohort 3b GSK2862277
Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days.
Arzneimittel: Repeat IH dose selected of GSK2862277 from Part 2
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
Experimental: Part 3: Cohort 3b Placebo
Matching placebo will be administered as IH daily for 5 days.
Arzneimittel: Matching placebo repeat dose IH
Matching placebo nebulised solution available for IH administration.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2
Zeitfenster: Up to 42 days
Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by number of subjects with AEs in Part 3
Zeitfenster: Up to 42 days
Safety and tolerability parameters will include recording of AEs, throughout the study.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by laboratory tests in Part 1 and Part 2
Zeitfenster: Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 as assessed by laboratory tests in Part 3
Zeitfenster: Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by vital signs in Part 1 and Part 2
Zeitfenster: Up to 42 days
Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by vital signs in Part 3
Zeitfenster: Up to 42 days
Vital signs will include BP, heart rate respiration rate and body temperature.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by ECG in Part 1 and Part 2
Zeitfenster: Up to 42 days
Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by ECG in Part 3
Zeitfenster: Up to 42 days
Safety data will include ECG readings obtained at each timepoint during the study.
Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 1 and Part 2
Zeitfenster: Up to 42 days
Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 3
Zeitfenster: Up to 42 days
Spirometry monitoring will include FEV1 and FVC.
Up to 42 days
Safety and tolerability of single IV dose of GSK2862277 as assessed by measurement of plasma cytokines in Part 1
Zeitfenster: Up to 42 days
Blood samples will be collected for assessment of plasma cytokines.
Up to 42 days
Immunogenicity in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Zeitfenster: Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Up to 60 days
Immunogenicity in subjects receiving repeat IV or IH dose of GSK2862277 in Part 3
Zeitfenster: Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Up to 60 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pharmacokinetic (PK) parameters in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Zeitfenster: Up to 48 hours post dose
The blood samples will be collected for plasma concentrations of GSK2862277.
Up to 48 hours post dose
PK parameters in subjects receiving repeat IV dose of GSK2862277 in Part 3 Cohort 3a
Zeitfenster: Up to 48 hours post last dose
The blood samples will be collected for plasma concentrations of GSK2862277.
Up to 48 hours post last dose
PK parameters in subjects receiving repeat IH dose of GSK2862277 in Part 3 Cohort 3b
Zeitfenster: Up to 48 hours post last dose
The blood samples will be collected for plasma concentrations of GSK2862277
Up to 48 hours post last dose
PK parameters in subjects receiving single IV dose of GSK2862277 in Part 1
Zeitfenster: Up to 48 hours post last dose
The PK parameters will be compared with historic GSK1995057 PK data in Part 1
Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Zeitfenster: Up to 48 hours post last dose
The pharmacodynamic and immune function biomarkers in serum.
Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving repeat IV or IH dose of GSK2862277in Part 3
Zeitfenster: Up to 48 hours post last dose
The pharmacodynamic and immune function biomarkers in serum.
Up to 48 hours post last dose
Change from baseline in IL-8 expression in ex vivo WBA in subjects receiving single IV 0.05 mg/kg dose of GSK2862277 in Part 1 in Cohort1c
Zeitfenster: Up to 12 hours post dose
IL-8 expression in ex vivo whole blood essay (WBA).
Up to 12 hours post dose
Composite of urine parameters in subjects receiving single IV 2 mg/kg dose of GSK2862277 in Part 2 in Cohort 2a
Zeitfenster: Up to 48 hours post dose
The urine samples will be collected for urine concentrations of GSK2862277.
Up to 48 hours post dose

Mitarbeiter und Ermittler

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

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

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. Februar 2013

Primärer Abschluss (Tatsächlich)

25. Oktober 2013

Studienabschluss (Tatsächlich)

25. Oktober 2013

Studienanmeldedaten

Zuerst eingereicht

14. Februar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. März 2013

Zuerst gepostet (Schätzen)

26. März 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2017

Zuletzt verifiziert

1. Mai 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 116343

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiendaten/Dokumente

  1. Datensatzspezifikation
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Einzelner Teilnehmerdatensatz
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinischer Studienbericht
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Kommentiertes Fallberichtsformular
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einwilligungserklärung
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistischer Analyseplan
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studienprotokoll
    Informationskennung: 116343
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

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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