Effect of Teduglutide on Gastric Emptying in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01209351|
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : November 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Placebo Drug: teduglutide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multiple Dosing, Parallel Group Study to Assess the Effects of Teduglutide (ALX-0600) on Gastric Emptying in Healthy Subjects|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2011|
Placebo Comparator: Placebo
teduglutide 4 mg
- PK log-transformed parameters AUC and CMax [ Time Frame: Day 10 ]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.
- AUC for each GI blood markers [ Time Frame: day 10 ]The secondary objectives of this study are to assess the effects of subcutaneous dosing of 4 mg of teduglutide administered in single daily doses on the pharmacokinetics of teduglutide on the AUC 3 hours post dose on insulin, glucose, and glucagon.
- CMax [ Time Frame: Day 10 ]The secondary objectives of this study are to assess the effects of subcutaneous dosing of 4 mg of teduglutide administered in single daily doses on the pharmacokinetics of teduglutide on the cMax 3 hours post dose on insulin, glucose, and glucagon.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209351
|United States, Texas|
|Cetero Clinical Research|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Jolene Berg, MD||Cetero Research, San Antonio|