Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 7/26/2017 |
| Start Date: | September 4, 2014 |
| End Date: | July 6, 2016 |
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects.
This trial is conducted in the United States of America (USA). The aim of the trial is to
investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the
body) for single doses of NNC9204-0530 alone and in combination with liraglutide in
overweight to obese but otherwise healthy male subjects.
investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the
body) for single doses of NNC9204-0530 alone and in combination with liraglutide in
overweight to obese but otherwise healthy male subjects.
Inclusion Criteria:
- Male, age between (both inclusive) 18 and 55 years at the time of signing inform
consent
- Overweight or obese but otherwise healthy male subjects; BMI of between or equal to
27.0 and 35.0 kg/m^2
Exclusion Criteria:
- Thyroid stimulating hormone values outside 0.4-6.0 mIU/l
- HbA1c (glycated hemoglobin) above or equal to 6.5%
- Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree
AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval
corrected by Fridericia formula) interval above 430 ms
- A history of additional risk factors for Torsades de pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
- Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia syndrome type 2
- Calcitonin above 50 ng/L
- History of pancreatitis (acute or chronic)
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