Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Sponsor
Novo Nordisk A/S
Study ID
NCT02210871
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.

Study Details

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.

Key Dates

Start date
Aug 7, 2014
Status verified
Dec 2017
Primary completion
Jun 3, 2015
Completion
Jun 3, 2015

Study Design

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

Arms

  • Experimental: Normal hepatic function
  • Experimental: Mild hepatic impairment
  • Experimental: Moderate hepatic impairment
  • Experimental: Severe hepatic impairment

Primary Outcome Measure

Area under the semaglutide plasma concentration-time curve [ Time Frame: Day 1 - day 36 ]

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