Clinical trial NCT02146079: A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
Official title: A Single-centre, Parallel-group, Randomised, Double-blind, Placebocontrolled, Multiple-dose Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-05-23
Enrollment: 44
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male Japanese and Caucasian subjects
* Age between 20 and 55 years (both inclusive) at the time of signing informed consent
* Body weight of equal to or above 54.0 kg
* Body mass index (BMI) between 20.0 and 25.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%
* For Japanese subjects only: both parents Japanese
* For Caucasian subjects only: both parents Caucasian

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2)
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Calcitonin above or equal to 50 ng/L
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits
* Smoking of more than 5 cigarettes (including nicotine substitute products) or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure
* Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted

Primary outcomes:
measure: Area under the plasma semaglutide concentration-time curve
timeFrame: During a dosing interval (0-168 hours) at steady state
Secondary outcomes:
measure: Maximum observed plasma semaglutide concentration at steady state
timeFrame: 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)
measure: Change in body weight from baseline to the end of treatment
timeFrame: Day 1 of Visit 2 (2-21 days after Visit 1), Day 92
measure: Number of treatment emergent adverse events (TEAEs) from baseline to follow-up
timeFrame: From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Ikushima I, Jensen L, Flint A, Nishida T, Zacho J, Irie S. A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects. Adv Ther. 2018 Apr;35(4):531-544. doi: 10.1007/s12325-018-0677-1. Epub 2018 Mar 13.