- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01572753
Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects
February 23, 2017 updated by: Novo Nordisk A/S
A Single Centre, Multiple Dose, Open Label Randomised Trial to Evaluate the Effect of Post Dose Meal Timings and the Effect of Volume of Water With Dosing on the Pharmacokinetic Properties of Oral Semaglutide in Healthy Male Subjects
This trial is conducted in Europe.
The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
161
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 14050
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory
- Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
- Suffer from a life threatening disease or has a history of any clinically significant disease or disorder
- History of acute idiopathic or chronic pancreatitis
- Calcitonin value equal to or above 50 ng/L
- Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10^9/L (normal range is 3.91 to 8.77x10^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L)
- Any clinically significant abnormal ECG, as judged by the investigator
- Subjects who are smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post-dose fasting 120 mins/50 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 60 mins/50 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 30 mins/50 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 15 mins/50 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 120 mins/120 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 60 mins/120 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 30 mins/120 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
Experimental: Post-dose fasting 15 mins/120 ml water
|
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 50 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 60 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 30 mins, no food or liquid is allowed.
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing).
Dose to be taken with 120 ml of water.
During the post-dose fasting period of 15 mins, no food or liquid is allowed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing
Time Frame: 0-24hrs after the 10th dosing
|
0-24hrs after the 10th dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax; The maximum plasma semaglutide concentration
Time Frame: Post-dose at day 10
|
Post-dose at day 10
|
tmax; Time to maximum plasma semaglutide concentration
Time Frame: Post-dose at day 10
|
Post-dose at day 10
|
t1/2; the terminal half-life of semaglutide
Time Frame: Post-dose at day 10
|
Post-dose at day 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baekdal TA, Breitschaft A, Donsmark M, Maarbjerg SJ, Sondergaard FL, Borregaard J. Effect of Various Dosing Conditions on the Pharmacokinetics of Oral Semaglutide, a Human Glucagon-Like Peptide-1 Analogue in a Tablet Formulation. Diabetes Ther. 2021 Jul;12(7):1915-1927. doi: 10.1007/s13300-021-01078-y. Epub 2021 Jun 2.
- Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2012
Primary Completion (Actual)
September 8, 2012
Study Completion (Actual)
September 8, 2012
Study Registration Dates
First Submitted
April 4, 2012
First Submitted That Met QC Criteria
April 4, 2012
First Posted (Estimate)
April 6, 2012
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 23, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9924-3794
- 2010-019653-17 (EudraCT Number)
- U1111-1120-6776 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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