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

• ClinicalTrials.gov Identifier: NCT05314283
• Recruitment Status: Completed
• First Posted: April 6, 2022
• Last Update Posted: November 17, 2022
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Tracking Information

• First Submitted Date: March 18, 2022
• First Posted Date: April 6, 2022
• Last Update Posted Date: November 17, 2022
• Actual Study Start Date: March 28, 2022
• Actual Primary Completion Date: November 8, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2022)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 29, 2022)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
• Official Title: A Feasibility Study Investigating the Safety, Performance and Gastrointestinal Transit of the DV3395 Device Concept in Healthy Participants.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Including a pilot cohort and a main cohort

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Healthy Volunteers, Medical Device

Intervention

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 .

Study Arms

Experimental: DV3395 C1

Intervention: Device: DV3395 C1

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2022): 65
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 8, 2022
• Actual Primary Completion Date: November 8, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT05314283
• Other Study ID Numbers: DV3395-4711; U1111-1253-1898 ( Other Identifier: World Health Organization (WHO) )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
• URL: http://novonordisk-trials.com

• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Novo Nordisk A/S
• Verification Date: November 2022