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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02060266

Collaborator

(none)

Enrollment

Location

Arm

2.7

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Healthy	Drug: semaglutide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 4, 2014

Actual Primary Completion Date :

Apr 28, 2014

Actual Study Completion Date :

Apr 28, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide	Drug: semaglutide Subjects will receive a single dose subcutaneously (s.c., under the skin).

Arm

Intervention/Treatment

Experimental: Semaglutide

Drug: semaglutide

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT02060266

Other Study ID Numbers:

NN9535-3789
2013-001769-18
U1111-1142-0810

First Posted:

Feb 12, 2014

Last Update Posted:

Mar 28, 2017

Last Verified:

Mar 1, 2017

Study Results

No Results Posted as of Mar 28, 2017