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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02060266

NN9535-3789

2013-001769-18 (EudraCT Number)

U1111-1142-0810 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Male

Ages

45 to 64 years old

Volunteers

Accepts Healthy Volunteers

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