Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Diabetes
Treatments
Drug: semaglutide
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
78 patients
Sex
All
Ages
18 to 75 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
78 participants in 3 patient groups
Fed conditions
Experimental group
Description:
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
Treatment:
Drug: semaglutide
Fasting conditions
Experimental group
Description:
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
Treatment:
Drug: semaglutide
Reference dosing condition
Experimental group
Description:
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
Treatment:
Drug: semaglutide
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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