Healthy Volunteers, Medical DevicePhase 1NCT05314283
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
A Phase 1 study testing DV3395 C1 in people with Healthy Volunteers, Medical Device, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Medical Device
- What is being tested?
- DV3395 C1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2022to 8 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Investigating the Safety, Performance and Gastrointestinal Transit of the DV3395 Device Concept in Healthy Participants.
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.
- Conditions
- Healthy Volunteers, Medical Device
- Being tested
- DV3395 C1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DV3395 C1Device
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 group | Role | What they receive |
|---|---|---|
| DV3395 C1 | Experimental | Not described Receives: Device: DV3395 C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of events
Measured: 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)
Secondary outcomes (3)
Confirmed DV3395 C1 integrity upon excretion (yes/no)
Count of participant
Measured: On day of excretion of DV3395 C1 (visit 2, expected between day 2 and day 5)
Confirmed gastric activation of DV3395 C1 (yes/no)
Count of participant
Measured: 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)
Time to activation of DV3395 C1
Minutes
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start28 Mar 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers, Medical DeviceStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Including a pilot cohort and a main cohort
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314283
- Sponsor's protocol ID
- DV3395-4711
- Other IDs
- U1111-1253-1898
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Investigating the Safety, Performance and Gastrointestinal Transit of the DV3395 Device Concept in Healthy Participants.
- ClinicalTrials.gov ID
- NCT05314283
- Acronym / sponsor ID
- DV3395-4711
- Conditions
- Healthy Volunteers, Medical Device
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Including a pilot cohort and a main cohort
| Arm | Type | Receives |
|---|---|---|
| DV3395 C1 | Experimental | Device: DV3395 C1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DV3395 C1Participants will be exposed to and swallow DV3395 C1 once. The participants will stay at the clinic research center for up to 6 days . | Device | DV3395 C1 |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DV3395 C1 in people with Healthy Volunteers, Medical Device, run by Novo Nordisk A/S at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.