DiabetesPhase 1NCT01037582
A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
A Phase 1 study testing NN9924 (oral), NN9924 (s.c.) and NN9924 (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 NN9924 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?
- NN9924 (oral), NN9924 (s.c.) and NN9924 (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
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Dec 2009to 7 May 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 Investigator
- Body weight of 65.0-95.0 kg (both inclusive)
- Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (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 Investigator
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 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 NN9924 in healthy male subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Being tested
- NN9924 (oral), placebo, NN9924 (s.c.), NN9924 (i.v.)
- 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.
NN9924 (oral)Drug
Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.
placeboDrug
Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
NN9924 (oral)Drug
Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
placeboDrug
Subjects will be randomized to receive a single dose of placebo.
NN9924 (s.c.)Drug
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
NN9924 (i.v.)Drug
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.
| Study group | Role | What they receive |
|---|---|---|
| Trial part 1 | Experimental | Not described Receives: Drug: NN9924 (oral); Drug: placebo |
| Trial part 2 | Experimental | Not described Receives: Drug: NN9924 (oral); Drug: placebo; Drug: NN9924 (s.c.); Drug: NN9924 (i.v.) |
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 NN9924 compared to i.v. and s.c. administration of the same compound
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 posted23 Dec 2009 (estimated)
- Study start17 Dec 2009
- Primary completion7 May 2010
- Study completion7 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 155 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
- NCT01037582
- Sponsor's protocol ID
- NN9924-3691
- Other IDs
- 2009-012366-31, U1111-1112-7564, 2009
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2009
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.
PubMed 30565096
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01037582
- Acronym / sponsor ID
- NN9924-3691
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2009 (actual)
- Primary completion
- 7 May 2010 (actual)
- Study completion
- 7 May 2010 (actual)
- First posted
- 23 Dec 2009 (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 NN9924 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: NN9924 (oral), Drug: placebo |
| Trial part 2 | Experimental | Drug: NN9924 (oral), Drug: placebo, Drug: NN9924 (s.c.), Drug: NN9924 (i.v.) |
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 Investigator
- Body weight of 65.0-95.0 kg (both inclusive)
- Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (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 Investigator
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator
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 |
|---|---|---|
| NN9924 (oral)Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation. | Drug | Trial part 1 |
| placeboSubjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels. | Drug | Trial part 1 |
| NN9924 (oral)Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1. | Drug | Trial part 2 |
| placeboSubjects will be randomized to receive a single dose of placebo. | Drug | Trial part 2 |
| NN9924 (s.c.)As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit | Drug | Trial part 2 |
| NN9924 (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 |
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 NN9924 compared to i.v. and s.c. administration of the same compound
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 3 Jan 2019.
- Derived from this study: PubMed 30565096Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.
- 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 NN9924 (oral), NN9924 (s.c.) and NN9924 (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 3 Jan 2019. 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?
On the ClinicalTrials.gov record for NCT01037582, which also lists 1 linked publication.
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 3 Jan 2019.