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A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

5. Dezember 2018 aktualisiert von: X4 Pharmaceuticals

A Phase 1 Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.

This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type).

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study will be conducted in 15 healthy volunteers at a clinical research unit located in Daytona Beach, Florida. Screening will be done within 35 days prior to the first dose of study drug (first Dosing Period). Each subject will complete two 10-day Dosing Periods, one using once daily dosing and the other twice daily dosing. The interval between the Dosing Periods will be 7 to 17 days. Patients will be randomly assigned to which regimen is administered the first Dosing Period. Safety laboratory tests will be performed at screening, and prior to and after each Dosing Period. End-of-Study (EOS) visit, the final study event, will be performed 14 to 21 days after the last dose of study drug.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

15

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

    • Florida
      • Daytona Beach, Florida, Vereinigte Staaten, 32117
        • Covance Cru, Inc.

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

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Between 18 and 65 years of age, inclusive.
  2. Have signed the current approved informed consent form.
  3. For women of childbearing potential, (a) agree to use effective contraceptive methods from screening, through the study, and for at least 4 weeks after the last dose of study drug; and (b) have a negative pregnancy test (serum or urine) at screening and on Day -1 prior to each Dosing period.
  4. For men, agree both to (a) use effective contraceptive methods and (b) abstain from donating sperm, from admission to the in-residence unit prior to the first Dosing Period, through the study, and for at least 4 weeks after the last dose of study drug.
  5. Be willing and able to comply with this protocol.

Exclusion Criteria:

  1. Is an employee of the Phase 1 unit or an immediate family member of an employee.
  2. Has a BMI <18.0 or >30.0.
  3. Has a history of hypersensitivity or allergy to any drug compound, food or other substance assessed as significant by the Investigator.
  4. Has a history or presence of any medical condition capable of altering absorption, metabolism or elimination of drugs (history of routine cholecystectomy is permitted).
  5. Has alcohol intake exceeding 21 units per week for males or 14 units per week for females, where 1 unit = 12 oz (360 mL) beer, 5 oz (150 mL) wine, or 1.5 oz (45 mL) distilled spirits.
  6. Has within the past 12 months used illicit drugs.
  7. Has within the past 6 months been a smoker or used tobacco or nicotine replacement products.
  8. Is within 6 months post-partum or termination of a pregnancy.
  9. Has within the past 30 days or 5 half-lives, whichever is longer, participated in any other clinical trial involving an investigational treatment.
  10. Has within the past 30 days had an acute medical illness, including an active infection.
  11. Has within the past 30 days donated more than 500 mL of blood.
  12. Has within the past 30 days, or is scheduled to have while participating in the study, surgery requiring general anesthesia.
  13. Has within the past 30 days, or is scheduled to have while participating in the study, any immunizations.
  14. Has within the past 14 days been nursing.
  15. Has within the past 14 days donated plasma.
  16. Has within the past 14 days used any prescription or over the counter medications, unless deemed acceptable by the Investigator.
  17. Has positive urine or serum test for drugs of abuse or for cotinine.
  18. Has positive serologic laboratory tests:

    • Human immunodeficiency virus (HIV-1 or -2)
    • Hepatitis C virus (HCV)
    • Hepatitis B virus (HBV)
  19. Has confirmed abnormal safety laboratory tests representing CTCAE Grade 2 or higher. Subjects with Grade 1 abnormalities may be enrolled with the approval of the Investigator and the Sponsor.
  20. Has insufficient venous access to permit the scheduled blood sampling.
  21. Has any other medical or personal condition or finding that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the subject, or may preclude the subject's successful completion of the clinical trial.

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: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: X4P-001 QD
Subjects will receive study drug in two dosing periods. In this arm subjects will receive drug once daily in the first period, followed by twice daily in the second dosing period.
100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.
Andere Namen:
  • AMD11070
Experimental: X4P-001 BID
Subjects will receive study drug in two dosing periods. In this arm subjects will receive drug twice daily in the first period, followed by once daily in the second dosing period.
100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.
Andere Namen:
  • AMD11070

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of treatment emergent adverse events (safety and tolerability) in subjects administered X4P-001 200 mg twice daily compared with 400 mg once daily.
Zeitfenster: Up to 14 to 21 days post-last dose
Safety assessments include ongoing monitoring of adverse events, ongoing monitoring of concomitant medications and regulatory scheduled vital signs, physical examinations and laboratory tests (hematology, clinical chemistry, urinalysis and coagulation).
Up to 14 to 21 days post-last dose
Maximum Plasma Concentration (Cmax) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
Zeitfenster: Up to 48 hours post-dose
Cmax data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Up to 48 hours post-dose
Area under the curve (AUC) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
Zeitfenster: Up to 48 hours post-dose
AUC data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Up to 48 hours post-dose
Minimum Plasma Concentration (Cmin) of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily.
Zeitfenster: Up to 48 hours post-dose
Amin data will be collected to determine the pharmacokinetics of X4P-001 administered as 200 mg twice daily and 400 mg once daily.
Up to 48 hours post-dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type).
Zeitfenster: Up to 48 hours post-dose
Whole blood samples will be obtained for PD studies concurrently with the PK samples. PD will be assessed via complete blood counts (CBC) with differential.
Up to 48 hours post-dose
To assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating mononuclear cell phenotypes by cell surface markers.
Zeitfenster: Up to 48 hours post-dose
Whole blood samples will be obtained for PD studies concurrently with the PK samples. PD will be assessed via complete blood counts (CBC) with differential.
Up to 48 hours post-dose

Mitarbeiter und Ermittler

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

Mitarbeiter

Ermittler

  • Studienleiter: Lu Gan, MD, PhD, X4 Pharmaceuticals, Inc.

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)

12. Januar 2016

Primärer Abschluss (Tatsächlich)

28. Februar 2016

Studienabschluss (Tatsächlich)

28. Februar 2016

Studienanmeldedaten

Zuerst eingereicht

4. Februar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Februar 2016

Zuerst gepostet (Schätzen)

12. Februar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Dezember 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Dezember 2018

Zuletzt verifiziert

1. Dezember 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • X4P-001-REGA

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

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 .

Klinische Studien zur X4P-001

3
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