Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

Sponsor
Novo Nordisk A/S
Study ID
NCT02016911
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.

Key Dates

Start date
Dec 12, 2013
Status verified
May 2018
Primary completion
Jan 12, 2015
Completion
Jan 12, 2015

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects with hepatic impairment
  • Active Comparator: Subjects with normal hepatic function

Primary Outcome Measure

Area under the semaglutide plasma concentration curve [ Time Frame: From time 0 to 24 hours after the 10th dosing ]

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