- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00728455
Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Phase
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
|
Expérimental: UN
|
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
|
Expérimental: 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
|
Expérimental: 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
|
Expérimental: Ré
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
Délai: Including screening and evaluation: after approx. 7 weeks
|
Including screening and evaluation: after approx. 7 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
AUC (area under the curve)
Délai: 21 days following dosing
|
21 days following dosing
|
Maximum plasma concentration
Délai: 21 days following dosing
|
21 days following dosing
|
Time to maximum plasma concentration
Délai: 21 days following dosing
|
21 days following dosing
|
Half life
Délai: 21 days following dosing
|
21 days following dosing
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NN9112-1905
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Essais cliniques sur NNC 0070-0002-0349
-
Novo Nordisk A/SRésiliéObésité | Trouble du métabolisme et de la nutritionÉtats-Unis
-
Janssen Research & Development, LLCComplétéInflammation | La maladie de CrohnBelgique, France, Israël, Hongrie, Fédération Russe, Pologne, Canada, États-Unis