Comparison of Three Liraglutide Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01514487
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.


Condition Intervention Phase
Diabetes
Healthy
Drug: liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the Curve (0-t) [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve (0-infinity) [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • Terminal elimination rate constant [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2005
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pH 7.7 Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subcutaneously
Experimental: pH 7.9 Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subcutaneously
Experimental: pH 8.15 Drug: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.
  • Body Mass Index (BMI) of 18-27 kg/m^2, both inclusive

Exclusion Criteria:

  • History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,
  • metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders
  • that may interfere with the objectives of the study, as judged by the investigator
  • Family or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia
  • Impaired renal function
  • Uncontrolled treated/untreated hypertension
  • Any clinically significant abnormal ECG
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunodeficiency virus) antibodies
  • Known or suspected allergy to trial product(s) or related products
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
  • Prescription or non-prescription medication, except for paracetamol and vitamins
  • History of alcoholism or drug abuse during the last 12 months
  • Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
  • Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514487

Locations
Australia
Adelaide, Australia, 5000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01514487     History of Changes
Other Study ID Numbers: NN2211-1636
Study First Received: January 17, 2012
Last Updated: January 20, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014