DiabetesPhase 1NCT01619345
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects
A Phase 1 study testing semaglutide in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- What is being tested?
- semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Aug 2012
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)
Who cannot join
- Males who are not willing to use two acceptable forms of highly effective contraception
- Participation in another clinical trial within 90 days
- Any chronic disorder or severe disease
- Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
- Subjects who are smokers
- Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.
- Being tested
- semaglutide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Also called NN9924
Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: NN9924 with 50 mL water | Experimental | Not described Receives: Drug: semaglutide |
| Period 2: NN9924 with 240 mL water | Experimental | Not described Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)
Measured: Assessed 0-4 hours post dose
Secondary outcomes (4)
Area under the NN9924 concentration curve
Measured: From time 0-24 hours
Anatomical location of initial tablet erosion (ITE)
Measured: Assessed 0-4 hours post dose
Time to ITE
Measured: Assessed 0-4 hours post dose
Time to CTE
Measured: Assessed 0-4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619345
- Sponsor's protocol ID
- NN9924-3957
- Other IDs
- 2011-004162-14, U1111-1123-7450
- Status last verified
- Feb 2015
- First submitted
- 12 Jun 2012
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01619345
- Acronym / sponsor ID
- NN9924-3957
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Jun 2012 (estimated)
- 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 trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: NN9924 with 50 mL water | Experimental | Drug: semaglutide |
| Period 2: NN9924 with 240 mL water | Experimental | Drug: semaglutide |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good general health
- Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)
Key exclusion criteria (6 listed)
- Males who are not willing to use two acceptable forms of highly effective contraception
- Participation in another clinical trial within 90 days
- Any chronic disorder or severe disease
- Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
- Subjects who are smokers
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 |
|---|---|---|
| semaglutideAlso: NN9924Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks. | Drug | Period 1: NN9924 with 50 mL water, Period 2: NN9924 with 240 mL water |
Primary outcome
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)
Time frame: Assessed 0-4 hours post dose
4 secondary outcomes
Area under the NN9924 concentration curve
Time frame: From time 0-24 hours
Anatomical location of initial tablet erosion (ITE)
Time frame: Assessed 0-4 hours post dose
Time to ITE
Time frame: Assessed 0-4 hours post dose
Time to CTE
Time frame: Assessed 0-4 hours post dose
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 23 Feb 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) 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 semaglutide in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 6 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 23 Feb 2015. 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 United Kingdom. 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?
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE) (time frame: Assessed 0-4 hours post dose). 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 23 Feb 2015.