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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016911
• Other study ID #: NN9924-4082
• Secondary ID: 2013-000550-21U1
• Status: Completed
• Phase: Phase 1
• Start date: December 12, 2013
• Est. completion date: January 12, 2015

Study information

• Verified date: May 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 12, 2015
• Est. primary completion date: January 12, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

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

Locations

Country	Name	City	State
Czechia	Novo Nordisk Investigational Site	Praha 10
Czechia	Novo Nordisk Investigational Site	Praha 7
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Wolomin
Slovakia	Novo Nordisk Investigational Site	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia, 

References & Publications (1)

Baekdal TA, Thomsen M, Kupcová V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Apr 25. doi: 10.1002/jcph.1131. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration curve		From time 0 to 24 hours after the 10th dosing
Secondary	Maximum observed semaglutide plasma concentration		0 to 24 hours after the 10th dosing
Secondary	Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve		From time 0 to 24 hours after the 10th dosing
Secondary	Maximum observed SNAC plasma concentration		0 to 24 hours after the 10th dosing

External Links

•   Clinical Trials at Novo Nordisk