Investigating the Pharmacokinetics of Subcutaneous Inject... | NCT02231684

ID	Type	Description	Link
2013-004566-34	EudraCT Number
U1111-1149-3980	Other Identifier	WHO

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)	Experimental	Drug: semaglutide
s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)	Experimental	Drug: semaglutide
s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)	Experimental	Drug: semaglutide
s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)	Experimental	Drug: semaglutide
s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)	Experimental	Drug: semaglutide
s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)	Experimental	Drug: semaglutide
i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).	s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)

Outcomes Module

Measure	Description	Time Frame
Area under the semaglutide plasma concentration curve		From day 0-day 35/840 hours

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed semaglutide plasma concentration		From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths
Area under the semaglutide plasma concentration-time curve		From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator)
Age between 18 and 55 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 20 and 30 kg/m^2 (both inclusive)

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1 % per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device) or sexual abstinence or vasectomised partner
Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
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 (male)/14 units (female) 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 products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases