A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
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|ClinicalTrials.gov Identifier: NCT05314283|
Recruitment Status : Completed
First Posted : April 6, 2022
Last Update Posted : November 17, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers, Medical Device||Device: DV3395 C1||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Including a pilot cohort and a main cohort|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study Investigating the Safety, Performance and Gastrointestinal Transit of the DV3395 Device Concept in Healthy Participants.|
|Actual Study Start Date :||March 28, 2022|
|Actual Primary Completion Date :||November 8, 2022|
|Actual Study Completion Date :||November 8, 2022|
|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 .
- Number of adverse events [ Time Frame: 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
- Confirmed DV3395 C1 integrity upon excretion (yes/no) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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).
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05314283
|Novo Nordisk Investigational Site|
|Groningen, Netherlands, 9728 NZ|
|Study Director:||Clinical Transparency (dept. 2834)||Novo Nordisk A/S|
|Responsible Party:||Novo Nordisk A/S|
|Other Study ID Numbers:||
U1111-1253-1898 ( Other Identifier: World Health Organization (WHO) )
|First Posted:||April 6, 2022 Key Record Dates|
|Last Update Posted:||November 17, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|