PMID- 24517114
OWN - NLM
STAT- MEDLINE
DCOM- 20140911
LR  - 20211021
IS  - 1471-230X (Electronic)
IS  - 1471-230X (Linking)
VI  - 14
DP  - 2014 Feb 12
TI  - A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group 
      clinical trial to assess the effects of teduglutide on gastric emptying of 
      liquids in healthy subjects.
PG  - 25
LID - 10.1186/1471-230X-14-25 [doi]
AB  - BACKGROUND: Teduglutide, a recombinant analog of human glucagon-like peptide 
      (GLP)-2, is a novel therapy recently approved for the treatment of adult patients 
      with short bowel syndrome who are dependent on parenteral support. Previous 
      studies assessing the effect of GLP-2 on gastric emptying in humans have yielded 
      inconsistent results, with some studies showing no effect and others documenting 
      a GLP-2-dependent delay in gastric emptying. The primary objective of this study 
      was to assess the effect of teduglutide on gastric emptying of liquids in healthy 
      subjects, as measured by the pharmacokinetics of acetaminophen. METHODS: This 
      double-blind, parallel-group, single-center study enrolled and randomized 36 
      healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 
      4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the 
      morning. Gastric emptying of a mixed nutrient liquid meal was assessed by 
      measuring acetaminophen levels predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 
      3, 3.5, 4, 5, 6, 8, 10, 12, and 14 hours after administration of 1000 mg 
      acetaminophen on Days 0 and 10. The primary study endpoint was a pharmacokinetic 
      analysis of acetaminophen absorption in subjects receiving teduglutide or 
      placebo. RESULTS: No significant differences in gastric emptying of liquids 
      (acetaminophen area under the concentration [AUC] vs time curve from time 0 to 
      the last measurable concentration, AUC extrapolated to infinity, maximum 
      concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects 
      receiving teduglutide 4 mg versus subjects receiving placebo. There were no 
      serious adverse events (AEs), deaths, or discontinuations due to an AE reported 
      during the study. CONCLUSIONS: Teduglutide 4 mg/day for 10 days does not affect 
      gastric emptying of liquids in healthy subjects as measured by acetaminophen 
      pharmacokinetics. No unexpected safety signals were observed. TRIAL REGISTRATION: 
      This study was registered at ClinicalTrials.gov, identifier NCT01209351.
FAU - Berg, Jolene Kay
AU  - Berg JK
AD  - DaVita Clinical Research, 825 S, 8th Street, Suite 300, Minneapolis, MN 55404, 
      USA. jolene.berg@davita.com.
FAU - Kim, Eric H
AU  - Kim EH
FAU - Li, Benjamin
AU  - Li B
FAU - Joelsson, Bo
AU  - Joelsson B
FAU - Youssef, Nader N
AU  - Youssef NN
LA  - eng
SI  - ClinicalTrials.gov/NCT01209351
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140212
PL  - England
TA  - BMC Gastroenterol
JT  - BMC gastroenterology
JID - 100968547
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Peptides)
RN  - 362O9ITL9D (Acetaminophen)
RN  - 7M19191IKG (teduglutide)
SB  - IM
MH  - Absorption/drug effects
MH  - Acetaminophen/*pharmacokinetics
MH  - Adult
MH  - Area Under Curve
MH  - Double-Blind Method
MH  - Female
MH  - Gastric Emptying/*drug effects
MH  - Gastrointestinal Agents/administration & dosage/*pharmacology
MH  - Humans
MH  - Male
MH  - Peptides/administration & dosage/*pharmacology
MH  - Young Adult
PMC - PMC3928318
EDAT- 2014/02/13 06:00
MHDA- 2014/09/12 06:00
PMCR- 2014/02/12
CRDT- 2014/02/13 06:00
PHST- 2013/04/04 00:00 [received]
PHST- 2014/01/24 00:00 [accepted]
PHST- 2014/02/13 06:00 [entrez]
PHST- 2014/02/13 06:00 [pubmed]
PHST- 2014/09/12 06:00 [medline]
PHST- 2014/02/12 00:00 [pmc-release]
AID - 1471-230X-14-25 [pii]
AID - 10.1186/1471-230X-14-25 [doi]
PST - epublish
SO  - BMC Gastroenterol. 2014 Feb 12;14:25. doi: 10.1186/1471-230X-14-25.