Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01572753
First received: April 4, 2012
Last updated: October 31, 2013
Last verified: October 2013

April 4, 2012
October 31, 2013
April 2012
September 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
AUC0-24hrs, Day10: Area under the NN9924 concentration curve [ Time Frame: From time 0-24hrs after the 10th dosing ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01572753 on ClinicalTrials.gov Archive Site
  • Cmax; The maximum plasma semaglutide concentration [ Time Frame: Post-dose at day 10 ] [ Designated as safety issue: No ]
  • tmax; Time to maximum plasma semaglutide concentration [ Time Frame: Post-dose at day 10 ] [ Designated as safety issue: No ]
  • t1/2; the terminal half-life of semaglutide [ Time Frame: Post-dose at day 10 ] [ Designated as safety issue: No ]
  • Cmax, Day10: The maximum plasma NN9924 concentration [ Time Frame: After 10 days of dosing ] [ Designated as safety issue: No ]
  • tmax, Day10 : Time to maximum plasma NN9924 concentration [ Time Frame: After 10 days of dosing ] [ Designated as safety issue: No ]
  • t½, Day10: The terminal half-life of NN9924 [ Time Frame: After 10 days of dosing ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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.
  • Drug: semaglutide
    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/50 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 60 mins/50 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 30 mins/50 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 15 mins/50 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 120 mins/120 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 60 mins/120 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 30 mins/120 ml water
    Intervention: Drug: semaglutide
  • Experimental: Post-dose fasting 15 mins/120 ml water
    Intervention: Drug: semaglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01572753
NN9924-3794, 2010-019653-17, U1111-1120-6776
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tine Aggerholm Bækdal Novo Nordisk A/S
Novo Nordisk A/S
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP