Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects
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
3 other identifiers
interventional
161
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 6, 2012
CompletedStudy Start
First participant enrolled
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2012
CompletedFebruary 27, 2017
February 1, 2017
5 months
April 4, 2012
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing
0-24hrs after the 10th dosing
Secondary Outcomes (3)
Cmax; The maximum plasma semaglutide concentration
Post-dose at day 10
tmax; Time to maximum plasma semaglutide concentration
Post-dose at day 10
t1/2; the terminal half-life of semaglutide
Post-dose at day 10
Study Arms (8)
Post-dose fasting 120 mins/50 ml water
EXPERIMENTALPost-dose fasting 60 mins/50 ml water
EXPERIMENTALPost-dose fasting 30 mins/50 ml water
EXPERIMENTALPost-dose fasting 15 mins/50 ml water
EXPERIMENTALPost-dose fasting 120 mins/120 ml water
EXPERIMENTALPost-dose fasting 60 mins/120 ml water
EXPERIMENTALPost-dose fasting 30 mins/120 ml water
EXPERIMENTALPost-dose fasting 15 mins/120 ml water
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Berlin, 14050, Germany
Related Publications (2)
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.
PMID: 34080123DERIVEDOvergaard 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.
PMID: 33969456DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2012
First Posted
April 6, 2012
Study Start
April 12, 2012
Primary Completion
September 8, 2012
Study Completion
September 8, 2012
Last Updated
February 27, 2017
Record last verified: 2017-02