First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/16/2019 |
| Start Date: | August 9, 2018 |
| End Date: | December 5, 2018 |
A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects
The aim of this study is to assess how safe the study drug is and how well a participant
tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the
concentration of the study drug and its breakdown products after a single dose. Participants
will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the
study medicine but without active ingredients) - which treatment any participant gets is
decided by chance. Participants will get one dose (can be one or two tablets) of study
medicine. The study will last for about 65 days. Participants will have 10 scheduled site
visits with the study physician or study staff at the study centre. For one of the visits,
participants will stay at the research unit for 5 days. At all visits, except the first
information visit, participants will have blood drawn along with other clinical assessments.
Participants cannot take part in this study if participants have any disorder that the doctor
thinks is a health problem. Only healthy men are allowed to take part.
tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the
concentration of the study drug and its breakdown products after a single dose. Participants
will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the
study medicine but without active ingredients) - which treatment any participant gets is
decided by chance. Participants will get one dose (can be one or two tablets) of study
medicine. The study will last for about 65 days. Participants will have 10 scheduled site
visits with the study physician or study staff at the study centre. For one of the visits,
participants will stay at the research unit for 5 days. At all visits, except the first
information visit, participants will have blood drawn along with other clinical assessments.
Participants cannot take part in this study if participants have any disorder that the doctor
thinks is a health problem. Only healthy men are allowed to take part.
Inclusion Criteria:
- Male aged 18 - 45 years (both inclusive) at the time of signing informed consent.
- Body mass index between 20.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).
- Considered to be generally healthy based on the medical history, physical examination,
and the results of vital signs, electrocardiogram and clinical laboratory tests
performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
- HbA1c greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Use of tobacco and nicotine products, defined as any of the below: 1) Smoking more
than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking
and use of nicotine substitute products during the in-house period.
- History of major surgical procedures involving the stomach potentially affecting
absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy,
gastric bypass surgery).
- Presence of clinically significant gastrointestinal disorders or symptoms of
gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as
judged by the investigator.
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or
medullary thyroid carcinoma.
- Presence or history of pancreatitis (acute or chronic).
We found this trial at
1
site
Click here to add this to my saved trials
