Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

Healthy Clinical Trial

Official title:

Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014259
• Other study ID #: NN9924-4079
• Secondary ID: 2013-000682-36U1
• Status: Completed
• Phase: Phase 1
• First received: December 12, 2013
• Last updated: April 17, 2018
• Start date: December 11, 2013
• Est. completion date: October 24, 2014

Study information

• Verified date: April 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 in subjects with various degrees of impaired renal function compared to subjects with normal renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 24, 2014
• Est. primary completion date: October 24, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18-85 years (both inclusive) at the time of signing inform consent

• Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)

• For subject with normal renal function: good general health (as judged by the investigator)

• 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 blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)

• 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
• Renal Insufficiency

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	Hradec Králové
Czechia	Novo Nordisk Investigational Site	Praha 7
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Czechia,  Hungary, 

References & Publications (1)

Granhall C, Søndergaard FL, Thomsen M, Anderson TW. Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment. Clin Pharmacokinet. 2018 Apr 6. doi: 10.1007/s40262-018-0649-2. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration time 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