NCT02146079CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Area under the plasma semaglutide concentration-time curve
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Semaglutide 0.5 mg
Experimental
Dose-escalation trial
Intervention: semaglutide (Drug)
Semaglutide placebo 0.5 mg
Placebo Comparator
Intervention: placebo (Drug)
Semaglutide 1.0 mg
Experimental
Dose-escalation trial
Intervention: semaglutide (Drug)
Semaglutide placebo 1.0 mg
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Area under the plasma semaglutide concentration-time curve
Time Frame: During a dosing interval (0-168 hours) at steady state
Secondary Outcomes
- Change in body weight from baseline to the end of treatment(Day 1 of Visit 2 (2-21 days after Visit 1), Day 92)
- Maximum observed plasma semaglutide concentration at steady state(0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg))
- 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))
Investigators
Study Sites (1)
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