A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects
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
3 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2014
CompletedStudy Start
First participant enrolled
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2014
CompletedApril 18, 2018
April 1, 2018
5 months
May 21, 2014
April 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the plasma semaglutide concentration-time curve
During a dosing interval (0-168 hours) at steady state
Secondary Outcomes (3)
Maximum observed plasma semaglutide concentration at steady state
0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)
Change in body weight from baseline to the end of treatment
Day 1 of Visit 2 (2-21 days after Visit 1), Day 92
Number of treatment emergent adverse events (TEAEs) from baseline to follow-up
From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)
Study Arms (4)
Semaglutide 0.5 mg
EXPERIMENTALDose-escalation trial
Semaglutide placebo 0.5 mg
PLACEBO COMPARATORSemaglutide 1.0 mg
EXPERIMENTALDose-escalation trial
Semaglutide placebo 1.0 mg
PLACEBO COMPARATORInterventions
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule
Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Tokyo, 130-0004, Japan
Related Publications (1)
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.
PMID: 29536338RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 23, 2014
Study Start
May 21, 2014
Primary Completion
October 20, 2014
Study Completion
October 20, 2014
Last Updated
April 18, 2018
Record last verified: 2018-04