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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-24

Study Completion Date

2015-04-01

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Semaglutide

Group Type EXPERIMENTAL

semaglutide

Intervention Type 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.

Semaglutide + Omeprazole

Group Type EXPERIMENTAL

semaglutide

Intervention Type 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

Intervention Type DRUG

Will be given daily with oral semaglutide.

Interventions

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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.

Intervention Type DRUG

Omeprazole

Will be given daily with oral semaglutide.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes