DiabetesPhase 1NCT01087645
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
A Phase 1 study testing NN9925 (oral) and NN9925 (i.v.) in people with Diabetes and Diabetes Mellitus, Type 2, 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 the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- What is being tested?
- NN9925 (oral) and NN9925 (i.v.)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2010to 16 Sep 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects with good general health as judged by the physician
- Body weight of 65-95 kg (both inclusive)
- Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)
Who cannot join
- Known or suspected allergy to trial product or related products
- Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Novo Nordisk Investigational Site
Nottingham, NG11 6JS
About this study
Official title: Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- NN9925 (oral), NN9925 (i.v.), placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NN9925 (oral)Drug
Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
NN9925 (i.v.)Drug
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
placeboDrug
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
NN9925 (oral)Drug
Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1
placeboDrug
Subjects will be randomised to receive a single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Trial part 1 | Experimental | Not described Receives: Drug: NN9925 (oral); Drug: placebo |
| Trial part 2 | Experimental | Not described Receives: Drug: NN9925 (i.v.); Drug: NN9925 (oral); Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events (AEs) recorded
Measured: from dosing to Day 22
Secondary outcomes (1)
The uptake in blood of oral NN9925
Measured: from 0 to 504 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study start12 Mar 2010
- Primary completion16 Sep 2010
- Study completion16 Sep 2010
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
- NCT01087645
- Sponsor's protocol ID
- NN9925-3779
- Other IDs
- 2009-016975-31, U1111-1113-2537, 2009
- Status last verified
- Feb 2017
- First submitted
- 12 Mar 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01087645
- Acronym / sponsor ID
- NN9925-3779
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2010 (actual)
- Primary completion
- 16 Sep 2010 (actual)
- Study completion
- 16 Sep 2010 (actual)
- First posted
- 16 Mar 2010 (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 the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial part 1 | Experimental | Drug: NN9925 (oral), Drug: placebo |
| Trial part 2 | Experimental | Drug: NN9925 (i.v.), Drug: NN9925 (oral), Drug: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects with good general health as judged by the physician
- Body weight of 65-95 kg (both inclusive)
- Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)
Key exclusion criteria (3 listed)
- Known or suspected allergy to trial product or related products
- Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
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 |
|---|---|---|
| NN9925 (oral)Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation | Drug | Trial part 1 |
| NN9925 (i.v.)As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit | Drug | Trial part 2 |
| placeboSubjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels | Drug | Trial part 1 |
| NN9925 (oral)Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1 | Drug | Trial part 2 |
| placeboSubjects will be randomised to receive a single dose of placebo | Drug | Trial part 2 |
Primary outcome
Number and severity of adverse events (AEs) recorded
Time frame: from dosing to Day 22
1 secondary outcome
The uptake in blood of oral NN9925
Time frame: from 0 to 504 hours
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 28 Feb 2017.
- 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 NN9925 (oral) and NN9925 (i.v.) in people with Diabetes and Diabetes Mellitus, Type 2, 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 3 inclusion and 3 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 28 Feb 2017. 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?
Number and severity of adverse events (AEs) recorded (time frame: from dosing to Day 22). 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 28 Feb 2017.