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

NCT00745186 | Completed Phase 1

• 1 other identifier: GLC061
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (19)

• 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.

• Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 0.2 mg Dose Level

  Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.

• Maximum Glucagon Concentration Observed (Cmax) for 0.2 mg Dose Level

  Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90 and 120 minutes.

Study Arms (2)

1

ACTIVE COMPARATOR

Glucagen

Drug: Glucagen

2

EXPERIMENTAL

Mayne Glucagon

Drug: Mayne Glucagon

Interventions

Glucagen DRUG

0.2 mg or 1 mg Glucagen single injection

1

Mayne Glucagon DRUG

0.2 mg or 1 mg Mayne Glucagon

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Charles River Laboratories

Edinburgh, EH14 4AP, United Kingdom

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stuart Mair

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: March 20, 2017

Record last verified: 2015-06

Locations

GB (1)