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

Sponsor
Novo Nordisk A/S
Study ID
NCT02064348
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.
  • placebo — DRUG
    Solution for s.c. injection or tablets for oral administration
  • moxifloxacin — DRUG
    Tablets for oral administration

Study Details

This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.

Key Dates

Start date
Feb 26, 2014
Status verified
Jun 2018
Primary completion
Apr 23, 2015
Completion
Apr 23, 2015

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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 [ Time Frame: 0-48 hours after the fourth dose of semaglutide/semaglutide placebo at the 1.5 mg dose level ]

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