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A research study of a new medicine NNC0519-0130 in Japanese and non-Japanese men

Completed
Conditions
type 2 diabetes
Registration Number
jRCT2071230015
Lead Sponsor
Novo Nordisk Pharma Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
70
Inclusion Criteria
  • Body mass index (BMI) between 23.0 kg/m2 and 39.9 kg/m2 (both inclusive) at screening with a minimum weight of 50 kg. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria
  • Any disorder, which in the investigator opinion might jeopardise safety of participant or compliance with the protocol.
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, GI, or endocrinological conditions.
  • HbA1c >= 6.5 % (48 mmol/mol) at screening. -Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.

Study & Design

Study Type
Interventional
Study Design
parallel assignment
Primary Outcome Measures
NameTimeMethod
Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment periodafter the last dose in each treatment period

Area under the NNC0519-0130 plasma concentration-time curve

Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment periodafter the last dose in each treatment period

Maximum plasma concentration of NNC0519-0130

Terminal half-life of NNC0519-0130 after the last doseafter the last dose

Terminal half-life of NNC0519-0130

Secondary Outcome Measures
NameTimeMethod

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