Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three different dosing conditions in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: semaglutide

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subject aged 18-75 years (both inclusive) at the time of signing informed consent
• Body mass index of 18.5-29.9 kg/m^2 (both inclusive)
• A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

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. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose of oral semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
• Not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit
• Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
• Previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fed conditions; Fasting for 10 hours overnight followed by a high-fat, high-calorie meal, after the meal dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours	Drug: semaglutide; For oral administration.
Experimental: Fasting conditions; Fasting for 10 hours overnight followed by dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours	Drug: semaglutide; For oral administration.
Experimental: Reference dosing condition; Fasting for 6 hours overnight followed by dosing of the tablet with 120 mL of water and a post-dose fasting period of 30 min	Drug: semaglutide; For oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the semaglutide plasma concentration time curve	From time 0 to 24 hours after the 10th daily dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed semaglutide plasma concentration	0 to 24 hours after the 10th daily dose
Time to maximum observed semaglutide plasma concentration	0 to 24 hours after the 10th daily dose
Terminal half-life of semaglutide	After the 10th daily dose
Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve	From time 0 to 24 hours after the 10th daily dose

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Baekdal TA, Breitschaft A, Donsmark M, Maarbjerg SJ, Sondergaard FL, Borregaard J. Effect of Various Dosing Conditions on the Pharmacokinetics of Oral Semaglutide, a Human Glucagon-Like Peptide-1 Analogue in a Tablet Formulation. Diabetes Ther. 2021 Jul;12(7):1915-1927. doi: 10.1007/s13300-021-01078-y. Epub 2021 Jun 2.
• 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NN9924-4154; 2013-004707-39 (EudraCT Number); U1111-1149-8127 (Other Identifier: WHO)