Status:
COMPLETED
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers, Medical Device
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 sto...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05314283
Start Date
March 28 2022
End Date
November 8 2022
Last Update
November 19 2024
Active Locations (1)
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1
ICON - location Groningen
Groningen, Netherlands, 9728 NZ