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

Last updated: August 9, 2018
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Diabetic Macular Edema

Diabetic Gastroparesis

Diabetic Foot Ulcers

Treatment

N/A

Clinical Study ID

NCT02249871
NN9924-4141
2013-005513-12
U1111-1151-5077
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 ofvital signs, electrocardiogram and laboratory safety tests performed during thescreening visit, as judged by the investigator

Exclusion

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using adequate contraceptive methods. Female of childbearing potential must use effective methods of birth control for the duration of thetrial and for 5 weeks following last dose. Only highly effective methods of birthcontrol are accepted (i.e., one that results in a less than 1% per year failure ratewhen used consistently and correctly, such as implants, injectables, combined oralcontraceptives, 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 mmHgand/or diastolic blood pressure above or equal to 90 mmHg). If white-coat hypertensionis 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 inexcess of 400 mL within the 3 months preceding screening

Study Design

Total Participants: 54
Study Start date:
September 24, 2014
Estimated Completion Date:
April 01, 2015

Connect with a study center

  • Novo Nordisk Investigational Site

    Berlin, 14050
    Germany

    Site Not Available

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