First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
Study Details
Study Description
Brief Summary
The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon (GlucaGen®). This is the first time NNC9204-1513 is given to humans.
Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is decided by chance (like flipping a coin). Neither the participant nor the study doctor will know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double -blinding). In case of emergency, this information will be readily available.
NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently not available on the market (doctors cannot prescribe this medicine). The participant will receive two or three single injections below the skin. One injection will contain NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that looks like the actual study drug but without any active ingredients. If a third injection is given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given using different devices and volumes. In order to mask these external differences, a "double dummy" approach will be used, that means when you get either of the study medicine (NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called 'placebo' (it will not have any effect on the body). Dependent on the injection volume to be administered, injections are given by either syringe with needle or an injection pen (NovoPen Echo®). The study will last for up to 39 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NNC9204-1513 Participants will receive increasing doses of NNC9204-1513. |
Drug: NNC9204-1513
Participants will receive NNC9204-1513 subcutaneous (s.c., in to a skin fold on the stomach) injection as single increasing doses of 0.01 mg, 0.04 mg, 0.10 mg, 0.25 mg, 0.50 mg, 1.0 mg or 2.0 mg. Each participant will only be given one dose.
Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
Drug: Placebo
Participants will receive single dose of placebo (for double dummy injections).
|
| Active Comparator: Glucagon Participants will receive a single fixed dose of glucagon. |
Drug: Glucagon
Participants will receive single dose of 1 mg glucagon s.c. injection.
Other Names:
Drug: Placebo
Participants will receive single dose of placebo (for double dummy injections).
|
Outcome Measures
Primary Outcome Measures
- Number of treatment emergent adverse events (TEAEs) [from time of dosing (day 1) to completion of the safety follow-up visit (day 8)]
Count of events
Secondary Outcome Measures
- Change from baseline in haematology [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in biochemistry [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in fibrinogen [baseline (day 1), follow-up visit (day 8)]
measured in g/L
- Change from baseline in lipids [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in glucose metabolism [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in hormones [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in urine dipstick parameter [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in systolic- and diastolic blood pressure [baseline (day 1), follow-up visit (day 8)]
Measured in mm Hg
- Change from baseline in body temperature [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in respiration rate [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in 12-lead electrocardiogram (ECG) heart rate [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in 12-lead ECG (RR interval) [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in 12-lead ECG (PR interval) [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in 12-lead ECG (QRS interval) [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in 12-lead ECG (QT interval) [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in 12-lead ECG (QTc intervals [Fridericia]) [baseline (day 1), follow-up visit (day 8)]
QT interval corrected for heart rate by Fridericia's formula
- Change from baseline in Physical examination [baseline (day 1), follow-up visit (day 8)]
- Incidence of injection site reactions [After administration of the trial products (day 1) until completion of the post-treatment follow-up visit (day 8).]
- AUC0-15min,SD, area under the plasma concentration time curve [0 to 15 minutes after single dose]
- t1/2,SD, terminal half-life [Measured for 24 hours after administration of a single s.c. dose]
- Onset of appearance [Measured for 24 hours after administration of a single s.c. dose]
Time from trial product administration until first time plasma concentration ≥ lower limit of quantification (LLOQ)
- AUCPG,0-15min,SD, area under the plasma glucose time curve [0 to 15 minutes after single dose]
- ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes [0 to 15 minutes after single dose]
Calculated as: Plasma glucose concentration at 15 minutes after single dose minus plasma glucose concentration at 0 minute
- Change from baseline in 12-lead ECG (overall evaluation) [baseline (day 1), follow-up visit (day 8)]
- Change from baseline in prothrombin time [baseline (day 1), follow-up visit (day 8)]
measured in seconds
- Change from baseline in Activated Partial Thromboplastin time (APTT) [baseline (day 1), follow-up visit (day 8)]
measured in seconds
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male, aged 18 -55 years (both inclusive), at the time of signing informed consent
-
Body mass index (BMI) between 18.5 and 28.0 kg/sqm (both inclusive)
-
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion Criteria:
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Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
-
Smoker (defined as a subject who is smoking at least one cigarette or equivalent daily) who is not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
-
Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Berlin | Germany | 10117 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9513-4290
- U1111-1180-8217
- 2016-001173-33