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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: semaglutide

• Registration Number: NCT02060266
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Primary Completion: 2014-04-28
• Study Completion: 2014-04-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semaglutide	semaglutide	-

Primary Outcome Measures

Name	Time	Method
Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces	Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide

Secondary Outcome Measures

Name	Time	Method
Total amount of [3H]-semaglutide related material excreted in urine (% of dose)	Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
Total amount of [3H]-semaglutide related material excreted in faeces (% of dose)	Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
Blood to plasma ratio of [3H]-semaglutide related material	Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
Area under the semaglutide plasma concentration curve	From time 0 until infinity after a single dose
Maximum observed semaglutide plasma concentration	After a single dose

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Groningen, Netherlands