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A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02064348
Collaborator
(none)
168
Enrollment
1
Location
3
Arms
13.8
Actual Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects: A Randomised, Double-Blind,Placebo-Controlled, Three-Arm Parallel Trial With a Nested Cross-Over Design for Positive Control With Moxifloxacin Administration
Actual Study Start Date :
Feb 26, 2014
Actual Primary Completion Date :
Apr 23, 2015
Actual Study Completion Date :
Apr 23, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: semaglutide + moxifloxacin placebo

Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment.

Drug: semaglutide
Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.

Drug: placebo
Solution for s.c. injection or tablets for oral administration
Active Comparator: Arm 2A:

Semaglutide placebo + moxifloxacin/moxifloxacin placebo: Subjects will receive moxifloxacin before the start of semaglutide placebo treatment and moxifloxacin placebo at the end of the semaglutide placebo treatment.

Drug: placebo
Solution for s.c. injection or tablets for oral administration

Drug: moxifloxacin
Tablets for oral administration
Experimental: Arm 2B:

Semaglutide placebo + moxifloxacin placebo/moxifloxacin: Subjects will receive moxifloxacin placebo before the start of semaglutide placebo treatment and moxifloxacin at the end of the semaglutide placebo treatment.

Drug: placebo
Solution for s.c. injection or tablets for oral administration

Drug: moxifloxacin
Tablets for oral administration

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Berlin Germany 14050

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02064348
Other Study ID Numbers:
  • NN9535-3652
  • 2012-005073-31
  • U1111-1136-6455
First Posted:
Feb 17, 2014
Last Update Posted:
Jun 13, 2018
Last Verified:
Jun 1, 2018
Additional relevant MeSH terms:
Moxifloxacin

Study Results

No Results Posted as of Jun 13, 2018