Feasibility Study of Exenatide by Continuous Subcutaneous Infusion
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/21/2017 |
| Start Date: | May 16, 2013 |
| End Date: | November 1, 2013 |
An Open-Label Exploratory Study to Investigate the Feasibility of Administering Exenatide by Continuous Subcutaneous Infusion to Healthy Subjects
This is an open-label study to investigate the feasibility of administering exenatide by
continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e.
Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours
followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B
approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum
of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
continuous subcutaneous infusion to healthy subjects. Study will consist of two parts i.e.
Part A and B. In Part A 2 healthy subjects will receive exenatide infusion over 24 hours
followed by a follow-up visit 10 to 14 days after discharge from clinic. In Part B
approximately 6 healthy subjects will receive subcutaneous infusions of exenatide for maximum
of 7 days followed by a follow-up visit 10 to 14 days after discharge from clinic.
Inclusion Criteria
- Male/females aged between 18 and 60 years of age inclusive, at the time of signing the
informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
12-lead ECG. A subject with a clinical abnormality or laboratory parameter(s) which
is/are not specifically listed in the inclusion or exclusion criteria, outside the
reference range for the population being studied may be included only if the
Investigator agrees and documents that the finding is unlikely to introduce additional
risk factors and will not interfere with the study procedures and objectives.
- Body Mass Index within the range 18 to 35 kilograms/meter squared (kg/m^2) inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential
defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or
postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases a
blood sample with simultaneous follicle stimulating hormone > 40 milli international
unit/mililiter (mL) and estradiol <40 picogram/mL (<147 picomoles/Liter) is
confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status
is in doubt will be required to use one of the contraception methods if they wish to
continue their HRT during the study. Otherwise, they must discontinue HRT to allow
confirmation of post-menopausal status prior to study enrollment.
- Child-bearing potential females must agree to use one of the contraception methods.
This criterion must be followed from the time of the first dose of study medication
until follow up visit.
- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
- Based on QT interval corrected for heart rate (QTc) of single electrocardiogram (ECG):
QTc by Fridericia's formula <450 millisecond (msec).
- Aspartate aminotransferase and Alanine aminotransferase <2x upper limit of normal
(ULN); alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria
- Subjects with a personal or family history of thyroid carcinoma or Type 2 Familial
Endocrine Neoplasia.
- History of uncorrected thyroid dysfunction or an abnormal thyroid functions as
assessed by thyroid stimulating hormones.
- Subjects with a history of severe gastrointestinal disease, or abnormal renal
function.
- Subjects with previous exposure to a Glucagon-like peptide-1 mimetic.
- History of chronic or acute pancreatitis. Note: Subjects with a lipase value above
1.5X ULN at screening are excluded.
- Current or chronic history of liver disease, or hepatic or biliary abnormalities (with
the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: An
average weekly intake of >14 drinks for males or >7 drinks for females. One drink is
equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of
wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy.
Criteria Based Upon Diagnostic Assessments
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening.
- A positive pre-study drug/alcohol screen.
- A subject with a positive urine cotinine test result will be excluded from the study
unless in the judgment of the Investigator the subject will be able to abstain from
using tobacco for the duration of the in-house period of the study.
- A positive test for human immuno virus antibody.
Other Criteria
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
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