Clinical trial NCT02060266: Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 7
Sex: MALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces
timeFrame: Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
Secondary outcomes:
measure: Total amount of [3H]-semaglutide related material excreted in urine (% of dose)
timeFrame: Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
measure: Total amount of [3H]-semaglutide related material excreted in faeces (% of dose)
timeFrame: Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
measure: Blood to plasma ratio of [3H]-semaglutide related material
timeFrame: Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide
measure: Area under the semaglutide plasma concentration curve
timeFrame: From time 0 until infinity after a single dose
measure: Maximum observed semaglutide plasma concentration
timeFrame: After a single dose
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Jensen L, Helleberg H, Roffel A, van Lier JJ, Bjornsdottir I, Pedersen PJ, Rowe E, Derving Karsbol J, Pedersen ML. Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species. Eur J Pharm Sci. 2017 Jun 15;104:31-41. doi: 10.1016/j.ejps.2017.03.020. Epub 2017 Mar 16.