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

Phase 1

Completed

• Conditions: Healthy Volunteers, Medical Device
• Interventions: Device: DV3395 C1

• Registration Number: NCT05314283
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-18
• Study Start: 2022-03-28
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DV3395 C1	DV3395 C1	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	From exposure (defined as when the participant takes DV3395-C1 into his/her hand with the intention of swallowing it) to DV3395 C1 on day 1 (visit 2) to 7 days after excretion of DV3395 C1 (phone visit 3, expected between day 9 and day 12)	Number of events

Secondary Outcome Measures

Name	Time	Method
Confirmed DV3395 C1 integrity upon excretion (yes/no)	On day of excretion of DV3395 C1 (visit 2, expected between day 2 and day 5)	Count of participant
Time to activation of DV3395 C1	From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)	Minutes
Confirmed gastric activation of DV3395 C1 (yes/no)	From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)	Count of participant

Trial Locations

Locations (1)

ICON - location Groningen; 🇳🇱 Groningen, Netherlands