Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to investigate bioequivalence between single-dose liraglutide administered subcutaneously with two different pen-injectors.

Official Title
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A Randomised, Open-label, Single-centre, Two-period, Cross-over Trial Investigating Bioequivalence Between Single-dose Liraglutide Administered Subcutaneously With Two Different Pen-injectors

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18-60 years (both inclusive) at the time of signing informed consent Body mass index (BMI) greater than or equal to 27.0 and less than 35.0 kg/m^2 Bodyweight up to 130.0 kg (inclusive) HbA1c (glycosylated haemoglobin) below 6.5% Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (incl. diabetes), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the trial, as judged by the investigator Use of any prescription or non-prescription medication, except for paracetamol, acetylsalicylic acid, contraceptives and vitamins (but including mega-dose vitamin therapy, as judged by the investigator) within 2 weeks before the trial defined as screening Significant history of alcoholism or drug/chemical abuse within 1 year from screening, or a positive result of the urine drug screen or alcohol breath test, or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine (120 mL), or 20 mL spirits) Smoking more than 5 cigarettes, or the equivalent, per day and unable to refrain from smoking during the in-house periods

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide 0.6 mg s.c. with FlexPen®<br> | Drug: liraglutide<br>* Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)<br>|
| Experimental: Liraglutide 0.6 mg s.c. with the PDS290 pen-injector<br> | Drug: liraglutide<br>* Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the liraglutide plasma concentration time curve from 0 to last quantifiable observation (tz) after single dose |  | 0-72 hours following administration of 0.6 mg liraglutide | 
| Maximum observed liraglutide plasma concentration after single dose |  | 0-72 hours following administration of 0.6 mg liraglutide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (TEAEs) |  | From baseline to follow-up (up to 3 weeks). Baseline is defined as time of first trial drug administration at Visit 2 |