- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01967589
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects
19. juni 2014 opdateret af: Novo Nordisk A/S
This trial is conducted in Europe.
The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
82
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Harrow, Det Forenede Kongerige, HA1 3UJ
-
-
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 64 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
- Age 18-64 years (both inclusive) at the time of signing informed consent
- BMI (body mass index) 20.0-29.9 kg/m^2 (both inclusive)
Exclusion Criteria:
- History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
- Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
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: DC (dosing condition)
Escalation design.
|
Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
|
Eksperimentel: Oral A
Escalation design.
Planned end-dose is 5 mg.
|
Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
|
Eksperimentel: Oral B
Escalation design.
Planned end-dose is 10 mg.
|
Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
|
Eksperimentel: Oral C
Escalation design.
Planned end-dose is 20 mg.
|
Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of treatment emergent adverse events (TEAEs) recorded
Tidsramme: From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
|
From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under the NNC0113-0987 plasma concentration curve
Tidsramme: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
|
During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
|
Maximum observed NNC0113-0987 plasma concentration
Tidsramme: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
|
During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
|
Time to maximum observed NNC0113-0987 plasma concentration
Tidsramme: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
|
During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
|
Change in fasting plasma glucose (FPG)
Tidsramme: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
|
From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
|
Change in HbA1C (glycosylated haemoglobin)
Tidsramme: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
|
From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
|
Change in body weight
Tidsramme: From baseline (Day -1) to after 10 weeks of treatment (Day 70)
|
From baseline (Day -1) to after 10 weeks of treatment (Day 70)
|
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. oktober 2013
Primær færdiggørelse (Faktiske)
1. maj 2014
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
18. oktober 2013
Først indsendt, der opfyldte QC-kriterier
18. oktober 2013
Først opslået (Skøn)
23. oktober 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- NN9926-3950
- 2012-002893-30 (EudraCT nummer)
- U1111-1131-8724 (Anden identifikator: WHO)
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 NNC0113-0987
-
Novo Nordisk A/SAfsluttet
-
Novo Nordisk A/SAfsluttetType 2 diabetes | Sunde frivilligeHolland
-
Novo Nordisk A/SAfsluttetDiabetes mellitus, type 2Forenede Stater
-
Novo Nordisk A/SRekruttering
-
Novo Nordisk A/SAfsluttetSund og rask | Diabetes mellitus, type 2 | DiabetesDet Forenede Kongerige
-
Novo Nordisk A/SAfsluttetType 2 diabetes | Sunde frivilligeTyskland