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A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose

30. April 2019 aktualisiert von: Mirum Pharmaceuticals, Inc.

A Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of [14C]-SHP626 Following a Single Oral Dose in Healthy Male Subjects

The purpose of this study is to determine how SHP626 is absorbed and excreted from the body in healthy males.

Studienübersicht

Status

Abgeschlossen

Studientyp

Interventionell

Einschreibung (Tatsächlich)

8

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

    • Wisconsin
      • Madison, Wisconsin, Vereinigte Staaten, 53704
        • Covance Madison Clinical Research Unit

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 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

Inclusion Criteria:

  1. Age between 18 and 50 years, inclusive, at the time of consent.
  2. Must be considered healthy. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, thyroid panel (includes T3, T4 and TSH at Screening only), blood chemistry, coagulation and urinalysis
  3. Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
  4. Ability to swallow all investigational product.
  5. A minimum of 1 bowel movement per day.

Exclusion Criteria:

  1. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gallbladder removal, gastric bypass surgery, ileal resection, any small intestinal resection,or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
  2. Current or relevant history of physical or psychiatric illness.
  3. Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
  4. Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
  5. Known history of alcohol or other substance abuse within the last year.
  6. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
  7. Within 30 days prior to the dose of investigational product:

    • Have used an investigational product (if elimination half-life is <6 days, otherwise 5 half-lives).
    • Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.
    • Have had any substantial changes in eating habits, as assessed by the investigator.
  8. Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
  9. Twelve-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject's eligibility.
  10. A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
  11. Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
  12. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
  13. Use of tobacco in any form
  14. Routine consumption of more than 2 units of caffeine per day
  15. Current use of any medication including over-the-counter, herbal, or homeopathic preparations
  16. An inability to follow a standardized diet and meal schedule or inability to fast
  17. Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
  18. Exposure to clinically significant radiation within 12 months prior to the dose of investigational product

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental Drug
single oral dose radiolabelled 50mg of SHP626
single oral dose 50mg SHP626 with approximately 5.95 μCi RAD

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Pharmacokinetic parameters will be determined from the plasma and blood concentration time data of total radioactivity and from the plasma concentration-time data for SHP626 by non-compartmental analysis.
Zeitfenster: Day 1 to day 10
Day 1 to day 10
Total radioactivity (RAD) in whole blood and plasma
Zeitfenster: Day 1 to day 10
Day 1 to day 10
To determine the total RAD in urine and feces.
Zeitfenster: Day 1 to day 10
Day 1 to day 10
Maximum plasma concentration (Cmax) of 50mg [14C]-SHP626 and RAD occurring at time of maximum observed concentration (tmax)
Zeitfenster: Day 1 to day 10
Day 1 to day 10
Area under the plasma concentration curve (AUC0-t) of 50mg [14C]-SHP626 and RAD from the time of dosing to the last measurable concentration
Zeitfenster: Day 1 to Day 10
Day 1 to Day 10
Area under the plasma concentration curve (AUC0-∞ ) of 50mg [14C]-SHP626 and RAD extrapolated to infinity, calculated using the observed value of the last non-zero plasma concentration
Zeitfenster: Day 1 to Day 10
Day 1 to Day 10
First order rate constant associated with the terminal portion of the plasma curve terminal half-life (t½) for 50mg [14C]-SHP626 and RAD
Zeitfenster: Day 1 to Day 10
Day 1 to Day 10
Total body clearance (CL/F ) of 50mg [14C]-SHP626 and RAD for extravascular administration divided by the fraction of dose absorbed
Zeitfenster: Day 1-10
Day 1-10
Volume of distribution (Vz/F ) of 50mg [14C]-SHP626 and RAD associated with the terminal slope following extra-vascular administration divided by the fraction of dose absorbed
Zeitfenster: Day 1-10
Day 1-10
Cumulative amount (Aef )of RAD recovered in stool over the dosing interval
Zeitfenster: Day 1-10
Day 1-10
Excreted Percent of RAD recovered in stool over the dosing interval
Zeitfenster: Day 1-10
Day 1-10
Cumulative amount (Aeu ) of RAD recovered in urine over the dosing interval
Zeitfenster: Day 1-10
Day 1-10
Excreted Percent of RAD recovered in urine over the dosing interval
Zeitfenster: Day 1-10
Day 1-10
Renal Clearance (CLR ) of 50mg [14C]-SHP626
Zeitfenster: Day 1 -10
Day 1 -10

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Characterize and identify metabolites of [14C]-SHP626 in plasma by accelerator mass spectrometry for radioactivity quantification
Zeitfenster: Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in urine by accelerator mass spectrometry for radioactivity quantification
Zeitfenster: Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Characterize and identify metabolites of [14C]-SHP626 in feces by liquid scintillation counting
Zeitfenster: Day 1 to day 10
Metabolites in the excreta and/or plasma will then be structurally identified by a combination of techniques such as co-chromatography with authentic reference standards, high performance liquid chromatography-mass spectrometry, and other spectroscopic techniques if necessary
Day 1 to day 10
Assess the safety and tolerability of [14C]-SHP626 by adverse events (AEs) defined as changes, including changes from baseline in physical examination findings
Zeitfenster: Screening to day 7
AEs will be coded using the agreed upon version of MedDRA. The number of events, incidence, and percentage of TEAEs will be calculated overall, by system organ class and by preferred term. TEAEs will be further summarized by severity and relationship to investigational product. AEs related to investigational product, AEs leading to withdrawal, SAEs, and deaths will be similarly summarized/listed.
Screening to day 7
Changes from baseline in vital signs
Zeitfenster: Screening to day 7
Screening to day 7
Changes from baseline in ECGs
Zeitfenster: Screening to day 7
Screening to day 7
Changes from baseline in hematology
Zeitfenster: Screening to day 7
Screening to day 7
Changes from baseline in coagulation
Zeitfenster: Screening to day 7
Screening to day 7
Changes in baseline in urinalysis
Zeitfenster: Screening to day 7
Screening to day 7
Changes in baseline in chemistry
Zeitfenster: Screening to day 7
Screening to day 7

Mitarbeiter und Ermittler

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

Ermittler

  • Hauptermittler: Nicholas Siebers, MD, Covance Clinical Pharmacology

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.

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. Oktober 2015

Primärer Abschluss (Tatsächlich)

1. Oktober 2015

Studienabschluss (Tatsächlich)

1. Oktober 2015

Studienanmeldedaten

Zuerst eingereicht

30. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Oktober 2015

Zuerst gepostet (Schätzen)

8. Oktober 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Mai 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • SHP626-102

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