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Completed

NCT Number: NCT02172313

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

For oral administration.

Primary outcomes

  1. Area under the semaglutide plasma concentration time curve

    Time frame: From time 0 to 24 hours after the 10th daily dose

Secondary outcomes

  1. Maximum observed semaglutide plasma concentration

    Time frame: 0 to 24 hours after the 10th daily dose

  2. Time to maximum observed semaglutide plasma concentration

    Time frame: 0 to 24 hours after the 10th daily dose

  3. Terminal half-life of semaglutide

    Time frame: After the 10th daily dose

  4. Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve

    Time frame: From time 0 to 24 hours after the 10th daily dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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