NCT02060266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2014

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

February 4, 2014

Last Update Submit

March 27, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

Semaglutide

EXPERIMENTAL
Drug: semaglutide

Interventions

semaglutideDRUG

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

Semaglutide

Eligibility Criteria

Age45 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28323117RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 12, 2014

Study Start

February 4, 2014

Primary Completion

April 28, 2014

Study Completion

April 28, 2014

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

NL(1)