- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01524770
A Study to Compare the Effect of Giving Dulaglutide Using an Auto-injector Versus a Manual Syringe
21. Oktober 2014 aktualisiert von: Eli Lilly and Company
Comparative Pharmacokinetics of Dulaglutide After Administration Via an Auto-injector and a Manual Syringe in Healthy Subjects
The study involves 2 injections of 1.5 milligrams (mg) dulaglutide, 1 given by a pre-filled manual syringe, the other given by an auto-injector.
Injections will be separated by a minimum 28-day washout period.
The study will evaluate if the levels of drug in the blood are similar when given by each method.
Participation in the study is likely to take approximately 7 weeks, not including screening.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
50
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
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Florida
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Daytona Beach, Florida, Vereinigte Staaten, 32117
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Are overtly healthy males or females, as determined by medical history and physical examination
- Male participants with female partners of child-bearing potential or partners who are pregnant or breastfeeding agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator
The method may be one of the following:
- condom with spermicidal agent
- male participant sterilization
- true abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable)
- Female participants not of child-bearing potential (that is, are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrollment
- Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or spontaneous amenorrhea for 6 to 12 months, with follicle stimulating hormone (FSH) ≥40 milli-international units per milliliters (mIU/mL)
- Female participants who have undergone sterilization by tubal ligation agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrollment
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meters squared (kg/m^2), inclusive, at screening
- Have clinical laboratory test results within the normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow for blood sampling as per the protocol
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Exclusion Criteria:
- Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to Glucagon-like peptide 1 (GLP-1) -related compounds including dulaglutide, or any components of the formulation
- Are persons who have previously completed or withdrawn from this study or any other study investigating dulaglutide in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure (after at least 5 minutes sitting) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric emptying (such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs. Participants with dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician
- Show evidence of significant active neuropsychiatric disease
- Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Are women with a positive pregnancy test or women who are lactating
- Have used or intend to use over-the-counter medication other than acetaminophen within 7 days prior to dosing or prescription medication (with the exception of vitamin/mineral supplements and/or hormone replacement therapy [HRT]) within 14 days prior to dosing
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to adhere to the alcohol restrictions (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Smoke more than 10 cigarettes (or equivalent in nicotine) per day, and are unwilling to refrain from smoking on the day of dulaglutide administration or are unable to abide by clinical research unit (CRU) restrictions
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
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: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Manual syringe
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28-day minimum washout period.
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Administered by subcutaneous (SC) injection
Andere Namen:
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Experimental: Auto-injector
Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28-day washout period
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Administered by subcutaneous (SC) injection
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide
Zeitfenster: Predose to 336 hours postdose
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Predose to 336 hours postdose
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Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide
Zeitfenster: Predose to 336 hours postdose
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Predose to 336 hours postdose
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide
Zeitfenster: Predose to 336 hours postdose
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Predose to 336 hours postdose
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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. März 2012
Primärer Abschluss (Tatsächlich)
1. Juni 2012
Studienabschluss (Tatsächlich)
1. Juni 2012
Studienanmeldedaten
Zuerst eingereicht
31. Januar 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Januar 2012
Zuerst gepostet (Schätzen)
2. Februar 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
22. Oktober 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Oktober 2014
Zuletzt verifiziert
1. Oktober 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 14142
- H9X-MC-GBDT (Andere Kennung: Eli Lilly and Company)
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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