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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

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

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.

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.

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

3
Abonner