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

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    65
  • sponsor
    Novo Nordisk A/S
Updated on 15 July 2022
Accepts healthy volunteers

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.

Details
Condition Healthy Volunteers, Medical Device
Treatment DV3395 C1
Clinical Study IdentifierNCT05314283
SponsorNovo Nordisk A/S
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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