A feasibility study investigating the safety, performance and gastrointestinal transit of the DV3395 device concept in healthy participants.
- Conditions
- Administration of protein-based medicines directly to the stomachMedical device for the administration of protein-based medicines directly in the stomach
- Registration Number
- NL-OMON50389
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
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).
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 < 3 bowel movements per week,
hard stools, or any other stool-related issues according to ROME IV criteria
for functional constipation) within 14 days prior to screening or between
screening and V2 pre-administration.
5. History of clinically significant gastrointestinal or abdominal surgery
(including gynaecological/obstetrical and urological procedures) as judged by
the investigator.
Further criteria apply. See protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the safety of DV3395-C1 in healthy participants.<br /><br>- Number of adverse events<br /><br>- Confirmed DV3395-C1 integrity upon excretion (yes/no)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the performance of DV3395-C1 in healthy participants.<br /><br>- Confirmed gastric activation of DV3395-C1 (yes/no)<br /><br>- Time to activation of DV3395-C1</p><br>