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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05314283

Collaborator

(none)

Enrollment

Location

Arm

6.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers, Medical Device	Device: DV3395 C1	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Including a pilot cohort and a main cohortIncluding a pilot cohort and a main cohort

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Oct 12, 2022

Anticipated Study Completion Date :

Oct 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DV3395 C1	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 .

Arm

Intervention/Treatment

Experimental: DV3395 C1

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 .

Outcome Measures

Primary Outcome Measures

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

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

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.
Body mass index between 18.5 and 29.9 kg/m^2 (both inclusive).

Exclusion criteria:

Presence of any known or suspected clinically significant gastrointestinal disease or gastrointestinal disorder (including functional and structural disorders) as judged by the investigator.
History of clinically significant gastrointestinal or abdominal surgery (including gynaecological/obstetrical and urological procedures) as judged by the investigator.
History of radiotherapy of the neck, thorax or abdomen.
Exposure to ionizing radiation from diagnostic or interventional procedures of greater than 0.1 mSv within 1 year prior to V2 pre-administration, a radiation burden of greater than 1.1 mSv within 2 years prior to V2 pre-administration, a radiation burden of greater than 2.1 mSv within 3 years prior to V2 pre administration, etc. (add 1 year per 1 mSv).
Known or suspected hypersensitivity to any component of DV3395 C1 or to any iodine based contrast agent.
Female for whom any of the below applies:
pregnant as determined by a positive laboratory pregnancy test at screening or at V2 pre administration
breast-feeding
of child-bearing potential and not using an adequate contraceptive method for 28 days or more prior to screening or between screening and V2 pre-administration, and not willing to maintain use of adequate contraception during the study period (adequate contraceptive measures as required by local regulation or practice)
wish to become pregnant within 6 months after the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT05314283

Other Study ID Numbers:

DV3395-4711
U1111-1253-1898

First Posted:

Apr 6, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 27, 2022