Clinical trial NCT02231684: Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
Official title: A Randomised, Single Centre, Two Period, Incomplete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.


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

Primary outcomes:
measure: Area under the semaglutide plasma concentration curve
timeFrame: From day 0-day 35/840 hours
Secondary outcomes:
measure: Maximum observed semaglutide plasma concentration
timeFrame: From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths
measure: Area under the semaglutide plasma concentration-time curve
timeFrame: From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2)
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: