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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01572753

2010-019653-17 (EudraCT Number)

NN9924-3794

U1111-1120-6776 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

161 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

161 participants in 8 patient groups

Post-dose fasting 120 mins/50 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 60 mins/50 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 30 mins/50 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 15 mins/50 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 120 mins/120 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 60 mins/120 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 30 mins/120 ml water

Experimental group

Treatment:

Drug: semaglutide

Post-dose fasting 15 mins/120 ml water

Experimental group

Treatment:

Drug: semaglutide

Trial contacts and locations

1

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