Clinical trial NCT02016911: Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Area under the semaglutide plasma concentration curve
timeFrame: From time 0 to 24 hours after the 10th dosing
Secondary outcomes:
measure: Maximum observed semaglutide plasma concentration
timeFrame: 0 to 24 hours after the 10th dosing
measure: Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve
timeFrame: From time 0 to 24 hours after the 10th dosing
measure: Maximum observed SNAC plasma concentration
timeFrame: 0 to 24 hours after the 10th dosing
Other outcomes:
Locations:
city: Praha 10
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 7
country: Czechia
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Wolomin
country: Poland
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Baekdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Oct;58(10):1314-1323. doi: 10.1002/jcph.1131. Epub 2018 Apr 25.
citation: Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.