NCT02249871

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

September 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

September 23, 2014

Last Update Submit

August 9, 2018

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Area under the semaglutide plasma concentration time curve

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

Secondary Outcomes (2)

  • Area under the SNAC plasma concentration time curve

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

  • Number of hypoglycaemic episodes

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

Study Arms (2)

Semaglutide

EXPERIMENTAL
Drug: semaglutide

Semaglutide + Omeprazole

EXPERIMENTAL
Drug: semaglutideDrug: Omeprazole

Interventions

semaglutideDRUG

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.

SemaglutideSemaglutide + Omeprazole
OmeprazoleDRUG

Will be given daily with oral semaglutide.

Semaglutide + Omeprazole

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (2)

  • Baekdal 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 Jun 30.

    PMID: 29897249RESULT

  • Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.

    PMID: 33969456DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutideOmeprazole

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 26, 2014

Study Start

September 24, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

DE(1)