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Mayne Glucagon

Phase 1

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

Mayne Glucagon development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2008

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

Mayne Glucagon clinical trials

Mayne Glucagon · 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
HypoglycemiaUnlock trial analytics

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 Mayne Glucagon

What is Mayne Glucagon?

Mayne Glucagon is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for hypoglycemia, a metabolic condition marked by low blood glucose. It is in Phase 1 clinical development. The program has studied a glucagon formulation for injection in healthy adult volunteers.

What is Mayne Glucagon used for?

Mayne Glucagon is being developed for hypoglycemia, a metabolic condition involving abnormally low blood glucose. The only clinical trial of the asset enrolled healthy adult volunteers rather than patients with hypoglycemia, and it evaluated the pharmacokinetics and pharmacodynamics of the injection.

Who makes Mayne Glucagon?

Mayne Glucagon is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program for the asset in hypoglycemia.

What phase is Mayne Glucagon in?

Mayne Glucagon is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials of the asset are currently active.

What clinical trials is Mayne Glucagon in?

Mayne Glucagon has been studied in one completed Phase 1 trial, NCT00745186, titled Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen (Novo Nordisk) in Healthy Volunteers. The trial enrolled 28 healthy adult participants in the United Kingdom and used an active-controlled, randomized design.

How did the Mayne Glucagon trial compare with Glucagen?

NCT00745186 compared the pharmacokinetics and pharmacodynamics of Mayne Glucagon for injection with Glucagen, a Novo Nordisk glucagon product, in healthy volunteers. The Phase 1 study was randomized and active-controlled, enrolled 28 participants aged 18 years and older in the United Kingdom, and has been completed.