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

Study identifier:H8O-EW-GWCI

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

exenatide, Moxifloxacin, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Apr 2008

Primary Completion Date: 01 Jul 2008

Study Completion Date: 01 Jul 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Experimental: Sequence 1 Period 1 = placebo exenatide/placebo moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin	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 2 Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin	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 3 Period 1 = placebo exenatide/moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/placebo moxifloxacin	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 4 Period I = placebo exenatide/moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin	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 5 Period I = placebo exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/moxifloxacin	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 6 Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin	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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

James Malone