JPRN-jRCT2071230015
Completed
Phase 1
Investigation of pharmacokinetics, safety, and tolerability of multiple oral and subcutaneous doses of NNC0519-0130 in Japanese and non-Japanese male participants
Tsukasaki Nobuaki0 sites70 target enrollmentMay 26, 2023
Conditionstype 2 diabetes
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- type 2 diabetes
- Sponsor
- Tsukasaki Nobuaki
- Enrollment
- 70
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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