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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060266
• Other study ID #: NN9535-3789
• Secondary ID: 2013-001769-18U1
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2014
• Last updated: March 27, 2017
• Start date: February 4, 2014
• Est. completion date: April 28, 2014

Study information

• Verified date: March 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 28, 2014
• Est. primary completion date: April 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Jensen L, Helleberg H, Roffel A, van Lier JJ, Bjørnsdottir I, Pedersen PJ, Rowe E, Karsbøl JD, Pedersen ML. Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species. Eur J Pharm Sci. 2017 Mar 16. pii: S0928- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood to plasma ratio of [3H]-semaglutide related material		Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
Secondary	Area under the semaglutide plasma concentration curve		From time 0 until infinity after a single dose
Secondary	Maximum observed semaglutide plasma concentration		After a single dose

External Links

•   Clinical Trials at Novo Nordisk