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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers, Medical Device

Treatments

Device: DV3395 C1

Study type

Interventional

Funder types

Industry

Identifiers

NCT05314283

DV3395-4711

U1111-1253-1898 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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