NL-OMON50389
Completed
Not Applicable
A feasibility study investigating the safety, performance and gastrointestinal transit of the DV3395 device concept in healthy participants. - DV3395 device concept feasibility study.
ovo Nordisk0 sites65 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovo Nordisk
- Enrollment
- 65
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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,
Outcomes
Primary Outcomes
Not specified
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