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Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00672399
First received: May 1, 2008
Last updated: June 6, 2014
Last verified: June 2014

May 1, 2008
June 6, 2014
April 2008
July 2008   (final data collection date for primary outcome measure)
Comparison of exenatide's effect on QT interval when compared to placebo [ Time Frame: single doses - measurements at 1, 2, 3, 4, 5.5 and 10 hours after dosing ] [ Designated as safety issue: No ]
To determine, in healthy subjects, that a single 10 μg dose of exenatide does not differ from placebo in the mean change from predose in 12-lead ECG correct QT (QTc) interval measurements
To determine, in healthy subjects, that a single 10 μg dose of exenatide does not differ from placebo in the mean change from predose in 12-lead ECG correct QT (QTc) interval measurements [ Time Frame: single doses ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00672399 on ClinicalTrials.gov Archive Site
  • Measurement of any QTcF changes following exenatide versus glucose, potassium, and insulin [ Time Frame: single doses - samples drawn at and EKGs at -15 min, hours 1, 2, 3, 4, 5.5, 10 ] [ Designated as safety issue: No ]
    To explore the influence of potential physiological covariates such as plasma insulin, plasma glucose, and potassium on QTc interval in healthy subjects
  • Assessment of plasma exenatide concentrations and QTc interval [ Time Frame: During Periods I, II, and III, ECGs should be recorded at the following ] [ Designated as safety issue: No ]
    Evaluation of the relationship between plasma exenatide concentrations and QTc interval in healthy subjects
  • To evaluate the relationship between plasma exenatide concentrations and QTc interval in healthy subjects. [ Time Frame: single doses ] [ Designated as safety issue: No ]
  • To explore the influence of potential physiological covariates such as plasma insulin, plasma glucose, and potassium on QTc interval in healthy subjects [ Time Frame: single doses ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects
A Placebo- and Positive-Controlled Study of the Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

This Phase 1, randomized, three period, placebo- and positive-controlled,double-blind, double-dummy, crossover study will be performed with approximately 80 healthy male and female subjects. The effects of single doses of exenatide (10 μg, subcutaneous), moxifloxacin (400 mg, oral) or placebo(subcutaneous or oral) on QT interval will be assessed.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Subjects
  • Drug: exenatide
    Subcutaneously injected, 10 mcg, single doses
    Other Name: Byetta
  • Drug: Moxifloxacin
    oral, 400 mg tablet, single doses
  • Drug: Placebo
    Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses
  • Experimental: Sequence 1
    Period 1 = placebo exenatide/placebo moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin
    Interventions:
    • Drug: exenatide
    • Drug: Moxifloxacin
    • Drug: Placebo
  • Experimental: Sequence 2
    Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin
    Interventions:
    • Drug: exenatide
    • Drug: Moxifloxacin
    • Drug: Placebo
  • Experimental: Sequence 3
    Period 1 = placebo exenatide/moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/placebo moxifloxacin
    Interventions:
    • Drug: exenatide
    • Drug: Moxifloxacin
    • Drug: Placebo
  • Experimental: Sequence 4
    Period I = placebo exenatide/moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin
    Interventions:
    • Drug: exenatide
    • Drug: Moxifloxacin
    • Drug: Placebo
  • Experimental: Sequence 5
    Period I = placebo exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/moxifloxacin
    Interventions:
    • Drug: exenatide
    • Drug: Moxifloxacin
    • Drug: Placebo
  • Experimental: Sequence 6
    Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin
    Interventions:
    • Drug: exenatide
    • Drug: Moxifloxacin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are between the ages of 18 and 65 years, inclusive.
  • Have body mass index (BMI) between 19 and 35 kg/m2, inclusive.
  • If females, are not of child-bearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they have had cessation of menses for at least 1 year or 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone >40 IU/mL; age ≥45 years; not taking oral contraceptives for at least 1 year; and otherwise healthy.
  • Subjects receiving hormone replacement therapy (HRT) or thyroxine as replacement therapy may participate providing they have been on stable therapy for at least 3 months and have a normal thyroid stimulating hormone (TSH) value.

Exclusion Criteria:

  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Known allergies to exenatide or excipients, moxifloxacin or related compounds, or a history of multiple adverse drug allergies of any origin.
  • Family history of sudden death.
  • Personal history of unexplained syncope within last year.
  • History or presence of cardiovascular (myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, GI, endocrine, haematological, or neurological disorders.
  • Evidence or history of Long QT Syndrome or significant active cardiac disease (e.g., arrhythmia, hypertension, congestive heart failure, hypokalaemia, mitral valve regurgitation, endocarditis, coronary artery heart disease), or symptoms of angina pectoris or transient ischaemic attacks within the previous 6 months.
  • Females who are lactating.
  • Have previously completed or withdrawn from this study or any other study investigating exenatide.
  • Evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
  • Evidence of hepatitis C and/or positive hepatitis C antibody.
  • Evidence of hepatitis B and/or positive hepatitis B surface antigen.
  • Use of over-the-counter or prescription medication (other than, for example, thyroid replacement, occasional intake of paracetamol, or vitamin or mineral supplements) 7 and 14 days, respectively, before dosing and throughout the study.
  • Cumulative blood donation of more than 500 mL within the last 3 months.
  • Subjects who have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or subjects unwilling to stop alcohol consumption for the duration of the study(1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
  • Subjects who smoke or have smoked within 28 days of their screening visit and who are unable to abide by the study restrictions.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00672399
H8O-EW-GWCI
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP