A research study of a new medicine NNC0519-0130 in Japanese and non-Japanese me
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-jRCT2071230015
- Lead Sponsor
- Tsukasaki Nobuaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 70
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.
- 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
- Not specified
- Primary Outcome Measures
Name Time Method -Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period<br>- Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period<br>- Terminal half-life of NNC0519-0130 after the last dose
- Secondary Outcome Measures
Name Time Method umber of treatment emergent adverse events