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Completed

NCT Number: NCT02249871

Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the influence of omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide 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

Novo Nordisk Investigational Site

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 age 18-75 years (both inclusive) at 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. 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 Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Hypertension (defined as sitting systolic blood pressure above or equal to 140 mmHg and/or diastolic blood pressure above or equal to 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
  • 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

Treatment and study plan

semaglutide

Drug

All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide.

Omeprazole

Drug

Will be given daily with oral semaglutide.

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. Area under the SNAC plasma concentration time curve

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

  2. Number of hypoglycaemic episodes

    Time frame: From first dosing (Day 1) to completion of the follow-up visit (Day 43 (± 2 days))

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 26, 2014
Registry last updated
Aug 13, 2018

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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