Overview

Effect of Teduglutide on Gastric Emptying in Healthy Subjects

Status:
Completed
Trial end date:
2010-11-08
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to assess the effects of 10 consecutive, daily, subcutaneous doses of 4 mg of teduglutide as compared with placebo on gastric emptying as assessed by acetaminophen absorption kinetics in healthy subjects.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Shire
Treatments:
Teduglutide
Criteria
Inclusion Criteria:

1. Informed of the nature of the study and have agreed to and are able to read, review,
understand, and sign the informed consent document prior to any screening assessments
being completed.

2. Completed the screening process within 30 days prior to check in

3. Adult males or females age 18 to 45 years in good health as determined by medical
history, physical examination, ECG, and laboratory tests

4. Women who are: (1) post-menopausal; (2) surgically sterilized, OR (3) of childbearing
potential with a negative pregnancy test at screening and check-in and who consent to
use an acceptable method of contraception for the duration of the study and for four
weeks following last dose of study drug.

Exclusion Criteria:

1. Allergy or sensitivity to acetaminophen

2. History of structural abnormality or pathology of the GI tract or diseases/conditions
which affect GI motility including the following:

Gastric, small bowel or colonic resection, Colon cancer or any GI Tract cancer Inflammatory
bowel disease, Irritable bowel disease, Diabetes Mellitus, Gallstones or cholecystectomy,
Appendectomy, hernia repair, benign polypectomy are not excluded, History of Gilbert's
Syndrome 3 History of hepatitis or pancreatitis 4 Evidence of any abnormal hepatobiliary
laboratory parameters (> ULN for serum ALT; AST; ALP; GGT; and/or total, direct or indirect
bilirubin) 5 Serum amylase or lipase above the upper limit of normal 6 Body mass index
(BMI) > 30 kg/m2 7 Intention to use medication that potentially affects GI tract motility 8
History of a viral or bacterial infection, allergy, other inflammatory process or surgery
within 3 weeks of the check-in day.

9 Clinical evidence or history (including that from medical and medication history,
physical examination, laboratory, ECG and any other available test results such as those
from medical imaging studies) of significant cardiovascular, respiratory, renal,
gastrointestinal, hematologic (eg, anemia), neurologic, psychiatric conditions or of any
disease that may interfere with the objectives of the study or with the subject
successfully completing the study 10 Presently taking prescription or over the counter
medication including products containing acetaminophen, vitamins, herbs or dietary
supplements, which cannot be discontinued. Prohibited medications must be discontinued at
least 7 days prior to check-in and all other medications and supplements must be stopped at
least 72 hours prior to check-in.

11 Current or recent history (within 12 months) of drug or alcohol abuse 12 Positive drug
or alcohol screen 13 Current or recent history (within 3 months) of use of tobacco products
14 Positive urine cotinine screen 15 Abnormalities in clinical chemistry, hematology,
urinalysis or in any other laboratory variables 16 Positive results in any of the virology
tests of acute or chronic infectious human immunodeficiency virus (HIV) and hepatitis virus
infections 17 Pregnant or lactating females; positive beta human chorionic gonadotropin
(b-hCG) pregnancy test in females only 18 Special dietary requirements which would preclude
a subject's acceptance of a high fat or high caloric, standardized meal 19 Blood donation
within 4 weeks of the check-in day 20 Participation in another clinical trial with an
investigational drug or device within the last month (if single dose) and at least 3 months
(if multiple dose) or within 10 times the half-life of the respective investigational drug,
whatever is longer, before the screening evaluation. For biologics the minimum period is at
least 6 months or the time of duration of the pharmacodynamic effect or 10 times the
half-life of the respective drug, whatever is longer, before the screening evaluation.

21 Lack of ability or willingness to give informed consent