First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

Novo Nordisk A/S36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes

Interventions

NNC9204-1513DRUG

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.

GlucagonDRUG

Participants will receive single dose of 1 mg glucagon s.c. injection.

PlaceboDRUG

Participants will receive single dose of placebo (for double dummy injections).

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * 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

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (TEAEs)

Count of events

Time frame: from time of dosing (day 1) to completion of the safety follow-up visit (day 8)

Secondary Outcomes

Change from baseline in haematology

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in biochemistry

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in fibrinogen

measured in g/L

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in lipids

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in glucose metabolism

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in hormones

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in urine dipstick parameter

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in systolic- and diastolic blood pressure

Measured in mm Hg

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in body temperature

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in respiration rate

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in 12-lead electrocardiogram (ECG) heart rate

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in 12-lead ECG (RR interval)

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in 12-lead ECG (PR interval)

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in 12-lead ECG (QRS interval)

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in 12-lead ECG (QT interval)

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in 12-lead ECG (QTc intervals [Fridericia])

QT interval corrected for heart rate by Fridericia's formula

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in Physical examination

Time frame: baseline (day 1), follow-up visit (day 8)

Incidence of injection site reactions

Time frame: 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

Time frame: 0 to 15 minutes after single dose

t1/2,SD, terminal half-life

Time frame: Measured for 24 hours after administration of a single s.c. dose

Onset of appearance

Time from trial product administration until first time plasma concentration ≥ lower limit of quantification (LLOQ)

Time frame: Measured for 24 hours after administration of a single s.c. dose

AUCPG,0-15min,SD, area under the plasma glucose time curve

Time frame: 0 to 15 minutes after single dose

ΔPG0-15min,SD, Increase in plasma glucose concentration from 0 to 15 minutes

Calculated as: Plasma glucose concentration at 15 minutes after single dose minus plasma glucose concentration at 0 minute

Time frame: 0 to 15 minutes after single dose

Change from baseline in 12-lead ECG (overall evaluation)

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in prothrombin time

measured in seconds

Time frame: baseline (day 1), follow-up visit (day 8)

Change from baseline in Activated Partial Thromboplastin time (APTT)

measured in seconds

Time frame: baseline (day 1), follow-up visit (day 8)

First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes