Clinical trial NCT02172313: Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Official title: Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the semaglutide plasma concentration time curve
timeFrame: From time 0 to 24 hours after the 10th daily dose
Secondary outcomes:
measure: Maximum observed semaglutide plasma concentration
timeFrame: 0 to 24 hours after the 10th daily dose
measure: Time to maximum observed semaglutide plasma concentration
timeFrame: 0 to 24 hours after the 10th daily dose
measure: Terminal half-life of semaglutide
timeFrame: After the 10th daily dose
measure: Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve
timeFrame: From time 0 to 24 hours after the 10th daily dose
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
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.