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Glucagen

Phase 1

Hypoglycemia | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Mar 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Glucagen · 1 trial · 1 indication

Phase 1 1
NCT00745186Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy VolunteersHypoglycemia
COMPLETED28 Analytics
PHASE1COMPLETED
Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
Hypoglycemia
NCT0074518628
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Study Endpoints

Primary Endpoints

Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25,30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.

Secondary Endpoints

Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Elimination half life (T1/2) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORGlucagen
2EXPERIMENTALMayne Glucagon

Interventions

NameTypeDescription
GlucagenDRUG0.2 mg or 1 mg Glucagen single injection
Mayne GlucagonDRUG0.2 mg or 1 mg Mayne Glucagon
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male or female aged 18-50 years inclusive * Body weight between 50 - 100 kg and body mass index (BMI) between 18 and 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator * Non-smokers or ex-smokers who have not smoked with in the...

Countries:United Kingdom
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Frequently asked questions about Glucagen

What is Glucagen used for?

Glucagen is used for hypoglycemia, a condition of abnormally low blood sugar. It is being developed as a small molecule treatment for this metabolic condition. The drug is currently in clinical development and is not yet approved for use.

Who makes Glucagen?

Glucagen is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating hypoglycemia.

What phase is Glucagen in?

Glucagen is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of testing in humans.

What clinical trials is Glucagen in?

Glucagen has one completed Phase 1 clinical trial, identified as NCT00745186. This study evaluated the pharmacokinetics and pharmacodynamics of Mayne Glucagon for Injection compared with Glucagen in healthy volunteers. The trial enrolled 28 participants and was conducted in the United Kingdom.

Is Glucagen the same as Mayne Glucagon?

Glucagen is being compared with Mayne Glucagon for Injection in a clinical trial. The study is designed to assess the pharmacokinetics and pharmacodynamics of Mayne Glucagon relative to Glucagen. The trial is active-controlled, meaning Glucagen serves as the comparator in this Phase 1 study.