DiabetesPhase 1NCT01978613
Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects
A Phase 1 study testing NNC0113-0987 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- What is being tested?
- NNC0113-0987
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Jun 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
- Age 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI): 20.0-29.9 kg/m^2 (both inclusive)
Who cannot join
- History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological,dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
- Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.
- Being tested
- NNC0113-0987, placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0113-0987Drug
Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.
placeboDrug
Tablets for one-daily oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Oral B (DC) | Experimental | Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing) Receives: Drug: NNC0113-0987; Drug: placebo |
| Oral D | Experimental | Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing) Receives: Drug: NNC0113-0987; Drug: placebo |
| Oral C | Experimental | Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing) Receives: Drug: NNC0113-0987; Drug: placebo |
| Oral B | Experimental | Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing) Receives: Drug: NNC0113-0987; Drug: placebo |
| Oral A | Experimental | Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing) Receives: Drug: NNC0113-0987; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events recorded
Measured: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
Secondary outcomes (3)
Number of hypoglycaemic episodes
Measured: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
Area under the NNC0113-0987 plasma concentration time curve
Measured: During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
Maximum observed NNC0113-0987 plasma concentration
Measured: During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- 100 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
- NCT01978613
- Sponsor's protocol ID
- NN9927-4022
- Other IDs
- 2013-000188-10, U1111-1138-4595
- Status last verified
- Jun 2014
- First submitted
- 1 Nov 2013
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01978613
- Acronym / sponsor ID
- NN9927-4022
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Nov 2013 (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 the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral B (DC) | Experimental | Drug: NNC0113-0987, Drug: placeboEscalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing) |
| Oral D | Experimental | Drug: NNC0113-0987, Drug: placeboEscalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral C | Experimental | Drug: NNC0113-0987, Drug: placeboEscalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral B | Experimental | Drug: NNC0113-0987, Drug: placeboEscalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral A | Experimental | Drug: NNC0113-0987, Drug: placeboEscalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
- Age 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI): 20.0-29.9 kg/m^2 (both inclusive)
Key exclusion criteria (5 listed)
- History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological,dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
- Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
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 |
|---|---|---|
| NNC0113-0987Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations. | Drug | Oral A, Oral B, Oral B (DC), Oral C, Oral D |
| placeboTablets for one-daily oral administration. | Drug | Oral A, Oral B, Oral B (DC), Oral C, Oral D |
Primary outcome
Number of treatment emergent adverse events recorded
Time frame: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
3 secondary outcomes
Number of hypoglycaemic episodes
Time frame: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)
Area under the NNC0113-0987 plasma concentration time curve
Time frame: During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
Maximum observed NNC0113-0987 plasma concentration
Time frame: During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)
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 30 Jun 2014.
- 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 NNC0113-0987 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
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 5 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 30 Jun 2014. 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 Germany. 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 treatment emergent adverse events recorded (time frame: From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)). 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 30 Jun 2014.