Effect of Food 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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-10-31

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) tablet formulation with three different dosing conditions 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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Fed conditions

Fasting for 10 hours overnight followed by a high-fat, high-calorie meal, after the meal dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

For oral administration.

Fasting conditions

Fasting for 10 hours overnight followed by dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

For oral administration.

Reference dosing condition

Fasting for 6 hours overnight followed by dosing of the tablet with 120 mL of water and a post-dose fasting period of 30 min

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

For oral administration.

Interventions

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semaglutide

For oral administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subject aged 18-75 years (both inclusive) at the 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 of oral semaglutide. 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, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit
* 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
* Previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes