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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249871
• Other study ID #: NN9924-4141
• Secondary ID: 2013-005513-12U1
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2014
• Est. completion date: April 1, 2015

Study information

• Verified date: August 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 1, 2015
• Est. primary completion date: April 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• semaglutide
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
Will be given daily with oral semaglutide.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bækdal TA, Breitschaft A, Navarria A, Hansen CW. A randomized study investigating the effect of omeprazole on the pharmacokinetics of oral semaglutide. Expert Opin Drug Metab Toxicol. 2018 Aug;14(8):869-877. doi: 10.1080/17425255.2018.1488965. Epub 2018 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration time curve		From time 0 to 24 hours after the 10th daily dose
Secondary	Area under the SNAC plasma concentration time curve		From time 0 to 24 hours after the 10th daily dose
Secondary	Number of hypoglycaemic episodes		From first dosing (Day 1) to completion of the follow-up visit (Day 43 (± 2 days))

External Links

•   Clinical Trials at Novo Nordisk