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Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers

Primary Purpose

Hypoglycemia

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Glucagen
Mayne Glucagon
Sponsored by
Hospira, now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 previous 3 months
  • Written informed consent given
  • Willing and able to comply with the requirements of the protocol and available for the planned duration of the study
  • Subject must agree to use an adequate method of contraception during the study and for 12 weeks after the last dose of investigational medicinal product (IMP). Adequate methods of contraception for subject or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilisation, subdermal implant, vasectomy, oral contraceptive pill, depot progesterone injections and abstinence. If a volunteer is usually not sexually active but becomes active he/she or their partner must use one of the contraceptive methods listed . Male subjects whose partner is of child bearing potential must ensure that they or their partner use effective contraception for the course of the study and 12 weeks thereafter

Exclusion Criteria:

  • History or presence of any clinically significant findings that, in the opinion of the investigator, would preclude inclusion in the study
  • History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
  • Any clinically significant laboratory findings
  • Clinically significant abnormalities in 12-lead electrocardiogram (ECG) results
  • Positive pregnancy test or lactation
  • Participation in any other clinical study using an investigational product or device within the previous 12 weeks
  • Positive human immunodeficiency virus (HIV), Hepatitis B or C test
  • History of drug or alcohol abuse within the past two years or alcohol consumption greater than 21 units per week for males and greater than 14 units per week for females
  • Blood donation of ≥ 500 mL in the previous 12 weeks
  • Hypersensitivity to Glucagon and/or any excipients
  • Use of prescription medicines or St John's Wort in the previous 2 weeks. The use of over-the-counter medicines within 5 days of dosing except those deemed by the investigator not to interfere with the outcome of the study. Vitamins, minerals and nutritional supplements may be taken at the discretion of the investigator. Hormonal contraceptives will be permitted.

Sites / Locations

  • Charles River Laboratories

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Glucagen

Mayne Glucagon

Outcomes

Primary Outcome Measures

Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level

Secondary Outcome Measures

Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Elimination half life (T1/2) for 1 mg Dose Level
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 0.2 mg Dose Level
Maximum Glucagon Concentration Observed (Cmax) for 0.2 mg Dose Level
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 0.2 mg Dose Level
Time at which Cmax occurs (Tmax) for 0.2 mg Dose Level
Elimination half-life (T1/2) for 0.2 mg Dose Level
Time at which Blood Glucose Cmax occurs (BG Tmax) for 1 mg Dose Level
Area under the curve from time 0 to return to baseline (rtb) for 1 mg Dose Level
Maximum absolute Blood Glucose excursion (MAE) from baseline for 1 mg Dose Level
Area under the glucose excursion versus time curve from 0 to rtb for 1 mg Dose Level
The earliest recorded time of the MAE for 1 mg Dose Level
Maximum Blood Glucose Concentration Observed (BG Cmax) for 0.2 mg Dose Level
Time at which Blood Glucose Cmax occurs (BG Tmax) for 0.2 mg Dose Level
Area under the curve from time 0 to return to baseline (rtb) for 0.2 mg Dose Level
Maximum absolute Blood Glucose excursion (MAE) from baseline for 0.2 mg Dose Level
Area under the glucose excursion versus time curve from 0 to rtb for 0.2 mg Dose Level
The earliest recorded time of the MAE for 0.2 mg Dose Level

Full Information

First Posted
September 2, 2008
Last Updated
March 16, 2017
Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00745186
Brief Title
Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers
Official Title
A Randomized, Open Label, Four Way Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety After Intramuscular (IM) Administration of Mayne Glucagon for Injection With Glucagen® (Novo Nordisk) in Healthy Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.
Detailed Description
Glucagon has been shown to be effective in the treatment of hypoglycemia, low blood sugar levels, in patients with diabetes. It primarily functions as a counter-regulatory hormone by opposing the actions of insulin to maintain blood glucose levels. A major problem for diabetic patients with hypoglycemia is the development of defective counter regulatory responses including reduced or absent glucagon responses to hypoglycemia. Mayne Glucagon for Injection has been developed as an alternative to currently marketed products. Administration of exogenous glucagon i.e., not produced in the body, has been shown to be effective in the treatment of low blood sugar in patients with diabetes. Mayne has developed a product, Glucagon for Injection, which is an alternative to currently marketed products. The only difference is the source of the active ingredient. The formulation, routes of administration, dosage regimen and indications of Mayne Glucagon for Injection are identical to those currently registered for the marketed product. A total of 28 healthy volunteers will be recruited into this study at one investigational site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Glucagen
Arm Title
2
Arm Type
Experimental
Arm Description
Mayne Glucagon
Intervention Type
Drug
Intervention Name(s)
Glucagen
Intervention Description
0.2 mg or 1 mg Glucagen single injection
Intervention Type
Drug
Intervention Name(s)
Mayne Glucagon
Intervention Description
0.2 mg or 1 mg Mayne Glucagon
Primary Outcome Measure Information:
Title
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Time Frame
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.
Title
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Time Frame
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.
Title
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level
Time Frame
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 Outcome Measure Information:
Title
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Time Frame
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.
Title
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Time Frame
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.
Title
Elimination half life (T1/2) for 1 mg Dose Level
Time Frame
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.
Title
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Maximum Glucagon Concentration Observed (Cmax) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Time at which Cmax occurs (Tmax) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Elimination half-life (T1/2) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Time at which Blood Glucose Cmax occurs (BG Tmax) for 1 mg Dose Level
Time Frame
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.
Title
Area under the curve from time 0 to return to baseline (rtb) for 1 mg Dose Level
Time Frame
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.
Title
Maximum absolute Blood Glucose excursion (MAE) from baseline for 1 mg Dose Level
Time Frame
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.
Title
Area under the glucose excursion versus time curve from 0 to rtb for 1 mg Dose Level
Time Frame
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.
Title
The earliest recorded time of the MAE for 1 mg Dose Level
Time Frame
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.
Title
Maximum Blood Glucose Concentration Observed (BG Cmax) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Time at which Blood Glucose Cmax occurs (BG Tmax) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Area under the curve from time 0 to return to baseline (rtb) for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Maximum absolute Blood Glucose excursion (MAE) from baseline for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
Area under the glucose excursion versus time curve from 0 to rtb for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.
Title
The earliest recorded time of the MAE for 0.2 mg Dose Level
Time Frame
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 previous 3 months Written informed consent given Willing and able to comply with the requirements of the protocol and available for the planned duration of the study Subject must agree to use an adequate method of contraception during the study and for 12 weeks after the last dose of investigational medicinal product (IMP). Adequate methods of contraception for subject or partner include condoms with spermicide gel, diaphragm with spermicide gel, coil (intrauterine device), surgical sterilisation, subdermal implant, vasectomy, oral contraceptive pill, depot progesterone injections and abstinence. If a volunteer is usually not sexually active but becomes active he/she or their partner must use one of the contraceptive methods listed . Male subjects whose partner is of child bearing potential must ensure that they or their partner use effective contraception for the course of the study and 12 weeks thereafter Exclusion Criteria: History or presence of any clinically significant findings that, in the opinion of the investigator, would preclude inclusion in the study History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug. Any clinically significant laboratory findings Clinically significant abnormalities in 12-lead electrocardiogram (ECG) results Positive pregnancy test or lactation Participation in any other clinical study using an investigational product or device within the previous 12 weeks Positive human immunodeficiency virus (HIV), Hepatitis B or C test History of drug or alcohol abuse within the past two years or alcohol consumption greater than 21 units per week for males and greater than 14 units per week for females Blood donation of ≥ 500 mL in the previous 12 weeks Hypersensitivity to Glucagon and/or any excipients Use of prescription medicines or St John's Wort in the previous 2 weeks. The use of over-the-counter medicines within 5 days of dosing except those deemed by the investigator not to interfere with the outcome of the study. Vitamins, minerals and nutritional supplements may be taken at the discretion of the investigator. Hormonal contraceptives will be permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Mair
Organizational Affiliation
Syneos Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles River Laboratories
City
Edinburgh
ZIP/Postal Code
EH14 4AP
Country
United Kingdom

12. IPD Sharing Statement

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Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers

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