Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male 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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-04

Study Completion Date

2014-04-28

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion after a single subcutaneous dose of \[3H\]-semaglutide in healthy male 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Semaglutide

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Subjects will receive a single dose subcutaneously (s.c., under the skin).

Interventions

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semaglutide

Subjects will receive a single dose subcutaneously (s.c., under the skin).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects, based on an assessment of medical history, physical examination, ECG (electrocardiogram) and vital signs, as determined by the investigator
* Age between 45-64 years (both inclusive) at the time of signing inform consent
* Body mass index (BMI) between 20 and 30 kg/m\^2 (both inclusive)

Exclusion Criteria

* Donation of any blood or plasma in the past month or in excess of 100 mL within the 3 months preceding screening, or surgery or trauma with more than 100 mL blood loss within the 3 months preceding screening
* Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2, Day 1
* History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
* Smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test

Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes