NCT05314283

A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.

A Feasibility Study Investigating the Safety, Performance and Gastrointestinal Transit of the DV3395 Device Concept in Healthy Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut. It will be checked if the device activates itself in the stomach as planned. Participants will be admitted to the clinic research center on day -1 and will receive the device on day 1 after 6 hours fast. The X-ray session will take up to 5 hours ending with administration of a small amount of contrast agent for better visualisation. The participants will stay at the clinic research center for up to 6 days until the device has been excreted. A follow-up phone call will take place 1 week after the device has been excreted.

Conditions

• Healthy Volunteers, Medical Device

Interventions

Type	Name	Description
DEVICE	DV3395 C1	Participants will be exposed to and swallow DV3395 C1 once. The participants will stay at the clinic research center for up to 6 days .

Timeline

• Start date: 2022-03-28
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2022-04-06
• Last updated: 2024-11-19

Locations

1 site across 1 country: Netherlands