A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose
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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53704
- Covance Madison Clinical Research Unit
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age between 18 and 50 years, inclusive, at the time of consent.
- 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
- Must have a body mass index between 18.0-30.0kg/m² inclusive with a body weight >50 kg (110 lbs).
- Ability to swallow all investigational product.
- A minimum of 1 bowel movement per day.
Exclusion Criteria:
- 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.
- Current or relevant history of physical or psychiatric illness.
- Known or suspected intolerance or hypersensitivity to the investigational product, or closely-related compounds, or any of the stated ingredients.
- Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.
- Known history of alcohol or other substance abuse within the last year.
- Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the dose of investigational product.
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.
- Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
- 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.
- A positive screen for drugs of abuse at Screening or a positive screen for alcohol or drugs of abuse at Check-in (Day -1).
- Male subjects who consume more than 21 units of alcohol per week or 3 units of alcohol per day.
- A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody screen.
- Use of tobacco in any form
- Routine consumption of more than 2 units of caffeine per day
- Current use of any medication including over-the-counter, herbal, or homeopathic preparations
- An inability to follow a standardized diet and meal schedule or inability to fast
- Have participated in a [14C]-study within the last 6 months prior to the dose of investigational product.
- Exposure to clinically significant radiation within 12 months prior to the dose of investigational product
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Experimental Drug
single oral dose radiolabelled 50mg of SHP626
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single oral dose 50mg SHP626 with approximately 5.95 μCi RAD
|
Was misst die Studie?
Primäre Ergebnismessungen
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
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Day 1 to day 10
|
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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
|
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Renal Clearance (CLR ) of 50mg [14C]-SHP626
Zeitfenster: Day 1 -10
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Day 1 -10
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Sekundäre Ergebnismessungen
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
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|
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
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Nicholas Siebers, MD, Covance Clinical Pharmacology
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- SHP626-102
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