Administration of protein-based medicines directly to the stomach Medical device for the administration of protein-based medicines directly in the stomach
Conditions
Interventions
The study device will be given once.
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male or female. 3. Aged 18-55 years (both inclusive) at the time of signing informed consent. 4. 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. 5. Body mass index between 18.5 and 29.9 kg/m2 (both inclusive).
Exclusion criteria
Exclusion criteria: 1. Any disorder, which in the investigator*s opinion might jeopardise participant*s safety or compliance with the protocol. 2. Presence of any known or suspected clinically significant GI disease or GI disorder (including functional and structural disorders) as judged by the investigator. 3. Presence of diarrhoea, defined as passage of three or more loose or liquid stools per day (or more frequent passage than is normal for the individual) within 14 days prior to screening or between screening and V2 pre-administration. 4. Presence of constipation (defined as having
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the safety of DV3395-C1 in healthy participants. - Number of adverse events - Confirmed DV3395-C1 integrity upon excretion (yes/no) | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the performance of DV3395-C1 in healthy participants. - Confirmed gastric activation of DV3395-C1 (yes/no) - Time to activation of DV3395-C1 | — |
Countries
Netherlands
Outcome results
None listed