Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02060266
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 4, 2014
Actual Primary Completion Date : April 28, 2014
Actual Study Completion Date : April 28, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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




Primary Outcome Measures :
  1. Concentration of the major metabolites of [3H]−semaglutide in plasma, urine, and faeces [ Time Frame: Up to 9 weeks following a single dose of 0.5 mg [3H]−semaglutide ]

Secondary Outcome Measures :
  1. Total amount of [3H]−semaglutide related material excreted in urine (% of dose) [ Time Frame: Up to 9 weeks following a single dose of 0.5 mg [3H]−semaglutide ]
  2. Total amount of [3H]−semaglutide related material excreted in faeces (% of dose) [ Time Frame: Up to 9 weeks following a single dose of 0.5 mg [3H]−semaglutide ]
  3. Blood to plasma ratio of [3H]−semaglutide related material [ Time Frame: Up to 9 weeks following a single dose of 0.5 mg [3H]−semaglutide ]
  4. Area under the semaglutide plasma concentration curve [ Time Frame: From time 0 until infinity after a single dose ]
  5. Maximum observed semaglutide plasma concentration [ Time Frame: After a single dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060266


Locations
Layout table for location information
Netherlands
Novo Nordisk Investigational Site
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02060266     History of Changes
Other Study ID Numbers: NN9535-3789
2013-001769-18 ( EudraCT Number )
U1111-1142-0810 ( Other Identifier: WHO )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017