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Completed

NCT Number: NCT02016911

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Prague, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
  • Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
  • History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
  • Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
  • History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

Treatment and study plan

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

Primary outcomes

  1. Area under the semaglutide plasma concentration curve

    Time frame: From time 0 to 24 hours after the 10th dosing

Secondary outcomes

  1. Maximum observed semaglutide plasma concentration

    Time frame: 0 to 24 hours after the 10th dosing

  2. Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve

    Time frame: From time 0 to 24 hours after the 10th dosing

  3. Maximum observed SNAC plasma concentration

    Time frame: 0 to 24 hours after the 10th dosing

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetics, 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 20, 2013
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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