Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
• Interventions: Drug: liraglutide-depot; Drug: placebo

• Registration Number: NCT01473953
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-06-20
• Results First Submitted QC: 2013-06-20
• Results First Posted: 2013-09-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

Inclusion Criteria

• Body mass index (BMI) between 20 and 35 kg/m^2 (both inclusive) with a body weight of at least 60 kg
• Apart from being obese (BMI above 30 kg/m^2) the subject has to be considered generally healthy

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Exclusion Criteria

• Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
• Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
• Prescription medicine and non-prescription medicine with few exceptions
• Current and prior history of alcohol or drug abuse
• Current smoking of more than 5 cigarettes per day
• Mental incapacity, language barriers, or unwillingness to comply with the protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4a: Lira-depot 30 mg	liraglutide-depot	-
Placebo	placebo	-
Cohort 1a: Lira-depot 2.25 mg	liraglutide-depot	-
Cohort 2a: Lira-depot 6.75 mg	liraglutide-depot	-
Cohort 3a: Lira-depot 15 mg	liraglutide-depot	-

Primary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events (TEAEs)	Day 0 and up to 21 days after treatment	TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot	Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity	Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment	1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose
Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot	Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment	0 to 168 hours after dosing
Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up	Day 0 and Day 21

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Evansville, Indiana, United States