Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers
16. oktober 2014 opdateret af: 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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Undersøgelsestype
Interventionel
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: EN
|
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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
Tidsramme: Including screening and evaluation: after approx. 7 weeks
|
Including screening and evaluation: after approx. 7 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
AUC (area under the curve)
Tidsramme: 21 days following dosing
|
21 days following dosing
|
|
Maximum plasma concentration
Tidsramme: 21 days following dosing
|
21 days following dosing
|
|
Time to maximum plasma concentration
Tidsramme: 21 days following dosing
|
21 days following dosing
|
|
Half life
Tidsramme: 21 days following dosing
|
21 days following dosing
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2008
Primær færdiggørelse (Forventet)
1. december 2009
Studieafslutning (Forventet)
1. december 2009
Datoer for studieregistrering
Først indsendt
31. juli 2008
Først indsendt, der opfyldte QC-kriterier
31. juli 2008
Først opslået (Skøn)
5. august 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN9112-1905
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med NNC 0070-0002-0349
-
Novo Nordisk A/SAfsluttetFedme | Metabolisme og ernæringsforstyrrelserForenede Stater
-
Janssen Research & Development, LLCAfsluttetBetændelse | Crohns sygdomBelgien, Frankrig, Israel, Ungarn, Den Russiske Føderation, Polen, Canada, Forenede Stater