Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.
Interventions
DRUGsemaglutide
Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.
DRUGplacebo
Solution for s.c. injection or tablets for oral administration
DRUGmoxifloxacin
Tablets for oral administration
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI (Body Mass Index): 20-30 kg/m\^2 * Body weight: 60-110 kg * Normal ECG (electrocardiogram)
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and 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 devices), or sexual abstinence or vasectomised partner * Any clinically significant disease history, in the opinion of the investigator, or systemic or organ * History of seizures, epilepsy, syncope, cardiac arrest, cardiac arrhythmia or Torsades de Pointes, A-V (Atrioventricular) block or structural heart disease * Family history of long QT (Interval in the ECG: from the start of the QRS complex to the end) syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative) * Family history of sudden cardiac death before the age of 50 of a 1st degree relative * 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 halflives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide * Smoking, drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points | 0-48 hours after the fourth dose of semaglutide/semaglutide placebo at the 1.5 mg dose level |
Secondary
| Measure | Time frame |
|---|---|
| QTcI, based on ECG (electrocardiogram) recordings obtained at 2 out of 8 time points | 0-24 hours after a single dose of moxifloxacin/moxifloxacin placebo |
Countries
Germany
Outcome results
None listed