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

Part of paid clinical trials in Evansville, Indiana.

Sponsor
Novo Nordisk A/S
Study ID
NCT01473953
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide-depot — DRUG
    Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.
  • placebo — DRUG
    Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).

Study Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
Mar 2017
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1a: Lira-depot 2.25 mg
  • Experimental: Cohort 2a: Lira-depot 6.75 mg
  • Experimental: Cohort 3a: Lira-depot 15 mg
  • Experimental: Cohort 4a: Lira-depot 30 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 0 and up to 21 days after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteEvansvilleIndiana47710-

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Novo Nordisk Investigational Site· Evansville, IN

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