Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers
16. Oktober 2014 aktualisiert von: Novo Nordisk A/S
Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects
This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.
Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.
Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.
Studienübersicht
Status
Zurückgezogen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Phase
- Phase 1
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 45 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
Inclusion Criteria:
- BMI greater than 27.0 and less than 35.0 kg/m2
Exclusion Criteria:
- Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
- Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
- Eating disorders
- Unusual diets or eating habits
- Dieting, use of diet drugs or obesity surgery
- Diabetes history or abnormal fasting glucose
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: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: E
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
Experimental: EIN
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
Experimental: B
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
Experimental: C
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
|
Experimental: D
|
Dose level 1: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: (6 subjects active, 2 subjects placebo).
Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 5 for s.c.
injection (6 subjects active, 2 subjects placebo)
Dose level 1: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 2: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 3: NNC 0070-0002-0349 placebo.
Subjects administered placebo will receive a subcutaneous injection.
Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c.
injection
Dose level 5: NNC 0070-0002-0349 placebo for s.c.
injection
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
Zeitfenster: Including screening and evaluation: after approx. 7 weeks
|
Including screening and evaluation: after approx. 7 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
AUC (area under the curve)
Zeitfenster: 21 days following dosing
|
21 days following dosing
|
|
Maximum plasma concentration
Zeitfenster: 21 days following dosing
|
21 days following dosing
|
|
Time to maximum plasma concentration
Zeitfenster: 21 days following dosing
|
21 days following dosing
|
|
Half life
Zeitfenster: 21 days following dosing
|
21 days following dosing
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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.
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
1. Juli 2008
Primärer Abschluss (Voraussichtlich)
1. Dezember 2009
Studienabschluss (Voraussichtlich)
1. Dezember 2009
Studienanmeldedaten
Zuerst eingereicht
31. Juli 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Juli 2008
Zuerst gepostet (Schätzen)
5. August 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. Oktober 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Oktober 2014
Zuletzt verifiziert
1. Oktober 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NN9112-1905
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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