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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-26

Study Completion Date

2015-04-23

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

Solution for s.c. injection or tablets for oral administration

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.

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

Solution for s.c. injection or tablets for oral administration

moxifloxacin

Intervention Type DRUG

Tablets for oral administration

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.

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Solution for s.c. injection or tablets for oral administration

moxifloxacin

Intervention Type DRUG

Tablets for oral administration

Interventions

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semaglutide

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

Intervention Type DRUG

placebo

Solution for s.c. injection or tablets for oral administration

Intervention Type DRUG

moxifloxacin

Tablets for oral administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes