Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers
16 oktober 2014 uppdaterad av: 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.
Studieöversikt
Status
Indragen
Betingelser
Studietyp
Interventionell
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: A
|
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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
Tidsram: Including screening and evaluation: after approx. 7 weeks
|
Including screening and evaluation: after approx. 7 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
AUC (area under the curve)
Tidsram: 21 days following dosing
|
21 days following dosing
|
|
Maximum plasma concentration
Tidsram: 21 days following dosing
|
21 days following dosing
|
|
Time to maximum plasma concentration
Tidsram: 21 days following dosing
|
21 days following dosing
|
|
Half life
Tidsram: 21 days following dosing
|
21 days following dosing
|
Samarbetspartners och utredare
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Sponsor
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2008
Primärt slutförande (Förväntat)
1 december 2009
Avslutad studie (Förväntat)
1 december 2009
Studieregistreringsdatum
Först inskickad
31 juli 2008
Först inskickad som uppfyllde QC-kriterierna
31 juli 2008
Första postat (Uppskatta)
5 augusti 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 oktober 2014
Senast verifierad
1 oktober 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NN9112-1905
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